Biologics

biologics
TitlePublishedFR Doc.Description
TitlePublishedFR Doc.Description
Health and Human Services Department -- Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; Corrections2018-May-222018-10923This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' (hereinafter referred to as the ``CY 2018 Quality Payment Program final rule'').
Health and Human Services Department -- Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products2018-Jan-262018-01468The Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
Health and Human Services Department -- Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Companion to Direct Final Rule2018-Jan-262018-01467The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is proposing this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Health and Human Services Department -- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program2017-Nov-152017-23953This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System2017-Nov-142017-24585The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software- assisted system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated indirect immunofluorescence microscope and software-assisted system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System2017-Nov-072017-24162The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System2017-Nov-072017-24159The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the genetic health risk assessment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the BCR-ABL Quantitation Test2017-Nov-012017-23742The Food and Drug Administration (FDA or we) is classifying the BCR-ABL quantitation test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the BCR-ABL quantitation test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test System2017-Oct-302017-23489The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Aquaporin-4 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based Assay2017-Oct-302017-23513The Food and Drug Administration (FDA or we) is classifying the Streptococcus spp. nucleic acid-based assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Streptococcus spp. nucleic acid-based assay's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency Disorder2017-Oct-302017-23496The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the newborn screening test for SCID's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test System2017-Oct-242017-22995The Food and Drug Administration (FDA or we) is classifying the zinc transporter 8 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the zinc transporter 8 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms2017-Oct-242017-23022The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mass spectrometer system for clinical use for the identification of microorganisms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis2017-Oct-242017-22994The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non- microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid2017-Oct-202017-22769The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens2017-Oct-162017-22287The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media2017-Oct-162017-22305The Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated image assessment system for microbial colonies on solid culture media's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays2017-Jul-272017-15858The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program2017-Jul-212017-14639This major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies.
Health and Human Services Department -- Medicare Program; CY 2018 Updates to the Quality Payment Program2017-Jun-302017-13010The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides proposed updates for the second and future years of the Quality Payment Program.
Commerce Department -- July 2017 Revision of Patent Cooperation Treaty Procedures2017-May-262017-10870The United States Patent and Trademark Office (USPTO or Office) is amending the rules of practice to implement certain amendments made to the Regulations under the Patent Cooperation Treaty (PCT) that will take effect on July 1, 2017, concerning the transmittal by a Receiving Office to an International Searching Authority of documents relating to an earlier search or classification.
Health and Human Services Department -- Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices2017-Apr-282017-07800We are proposing to revise 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 for FY 2018. Some of these proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the proposed estimated market basket update that would apply 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 for FY 2018. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table2017-Jan-192017-00701On July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, ``Adverse Effects of Vaccines: Evidence and Causality,'' the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations. The Secretary amends the Table through the changes in this final rule. These changes will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements2017-Jan-192017-00726In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.
Health and Human Services Department -- Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens2017-Jan-122017-00199The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
Health and Human Services Department -- 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation2017-Jan-052016-31935The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).
Health and Human Services Department -- Submission of Food and Drug Administration Import Data in the Automated Commercial Environment2016-Nov-292016-28582The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
Health and Human Services Department -- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements2016-Nov-152016-26668This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.
Health and Human Services Department -- Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models2016-Nov-042016-25240The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.
Commerce Department -- Revision of the Duty To Disclose Information in Patent Applications and Reexamination Proceedings2016-Oct-282016-25966The United States Patent and Trademark Office (Office or PTO) is proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings (duty of disclosure) in light of a 2011 decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). The Office previously issued a notice of proposed rulemaking on July 21, 2011, and due to the passage of time since the comment period closed in 2011, the Office considers it appropriate to seek additional comments from our stakeholders before issuing a final rulemaking. In the current notice of proposed rulemaking, the Office is seeking public comments on the rules of practice, as revised in response to the comments received from our stakeholders.
Health and Human Services Department -- Clinical Trials Registration and Results Information Submission2016-Sep-212016-22129This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins2016-Sep-142016-22049The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.
Health and Human Services Department -- Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program2016-Sep-132016-21888This action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the smallpox countermeasure injury coverage under the Public Readiness and Emergency Preparedness Act of 2005 and its authorization of the Countermeasures Injury Compensation Program.
Health and Human Services Department -- Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs2016-Aug-312016-20471The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.
Health and Human Services Department -- 340B Drug Pricing Program; Administrative Dispute Resolution2016-Aug-122016-18969The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.
Health and Human Services Department -- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model2016-Jul-152016-16097This major proposed rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes proposals related to the Medicare Shared Saving Program, and the release of certain pricing data from Medicare Advantage bids and medical loss ratio reports from Medicare health and drug plans. In addition, this rule proposes to expand the Medicare Diabetes Prevention Program model.
Health and Human Services Department -- Submission of Food and Drug Administration Import Data in the Automated Commercial Environment2016-Jul-012016-15684The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the ``single window'' for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
Health and Human Services Department -- Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products2016-Jun-222016-14721The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
Health and Human Services Department -- Use of Symbols in Labeling2016-Jun-152016-13989The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as ``stand-alone symbols'') if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement ``Rx only'' or ``[rx] only'' in the labeling for prescription devices.
Health and Human Services Department -- Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models2016-May-092016-10032Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.
Health and Human Services Department -- Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule2016-May-042016-10386The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.
Health and Human Services Department -- Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products2016-May-042016-10385The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.
Health and Human Services Department -- Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 19722016-Feb-122016-02884The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements2016-Jan-192016-00758In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, we are proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.
Health and Human Services Department -- Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment2015-Dec-282015-32477The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) ``lookback'' requirements regarding review of historical testing records. FDA is taking this action because the HCV ``lookback'' regulations based on review of historical testing records expired on August 24, 2015, due to the sunset provision provided under the regulation.
Health and Human Services Department -- Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph2015-Dec-232015-32246The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.
Health and Human Services Department -- Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection2015-Nov-172015-29275The Food and Drug Administration (FDA) is re-proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is re-proposing to establish special controls in a draft special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. In addition, FDA is re-proposing to restrict use and distribution of the devices. FDA is publishing in this proposed rule the recommendations of the Panel regarding the classification of the devices.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay2015-Nov-022015-27817The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System2015-Oct-272015-27197The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay2015-Aug-272015-21237The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Countermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury Table2015-Aug-072015-19228HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds regulations for the purpose of creating Covered Countermeasures Injury Tables. The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus (hereafter referred to as the 2009 H1N1 virus) and other potential pandemic strains, such as H5N1 avian influenza.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis2015-Aug-042015-19072The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table2015-Jul-292015-17503The Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.
Health and Human Services Department -- Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products2015-Jul-082015-16659The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
Health and Human Services Department -- Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 19722015-Jul-022015-16367The Food and Drug Administration (FDA) proposes to remove two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
Health and Human Services Department -- Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications2015-Jul-022015-16366The Food and Drug Administration (FDA) is amending the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is finalizing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics license applications (BLAs), or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to the Executive order.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table2015-Jun-232015-14771On July 24, 2013, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table). The basis for this change is consistent with the Secretary's findings that intussusceptions can reasonably be determined in some circumstances to be caused by rotavirus vaccines. The Secretary is now making this amendment to the Table and to the Qualifications and Aids to Interpretation (QAI), described below under Background Information, as proposed in the NPRM. These regulations will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.
Health and Human Services Department -- 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation2015-Jun-172015-14648The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures2015-May-272015-12741The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use2015-May-222015-12228The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.
Health and Human Services Department -- Food and Drug Administration Regulations; Change of Addresses; Technical Amendment2015-Apr-032015-07268The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.
Health and Human Services Department -- Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products2014-Dec-312014-30528The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is proposing this action in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
Health and Human Services Department -- Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products2014-Dec-182014-29522The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.
Health and Human Services Department -- Clinical Trials Registration and Results Submission2014-Nov-212014-26197This Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM). This proposed rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance2014-Oct-222014-25049The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System2014-Sep-182014-22254The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents2014-Sep-102014-21479The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Medical Devices; Technical Amendment2014-Aug-252014-20107The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to correct outdated Web site addresses.
Health and Human Services Department -- Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications2014-Aug-222014-19888The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is proposing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to an Executive order.
Health and Human Services Department -- Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements2014-Jun-102014-13480The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
Health and Human Services Department -- Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens2014-May-302014-12544The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents2014-May-302014-12545The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens2014-May-222014-11635The Food and Drug Administration (FDA) is proposing to reclassify antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Technical Amendment2014-May-122014-10740In a final rule that was published in the Federal Register on October 5, 2012, we amended and republished the list of select agents and toxins that have the potential to pose a severe threat to public health and safety; reorganized the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human health (designation of Tier 1); and amended the regulations in order to add definitions and clarify language concerning security, training, biosafety, biocontainment, and incident response. In that final rule, all of our regulatory language was not precisely aligned with that used by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA) in their parallel select agent regulations published on the same day in the Federal Register. This document corrects inconsistencies in language between the HHS/CDC and USDA/APHIS regulations. We are also correcting an improper term used in those sections of the regulations associated with identification of a viral strain or subspecies that is excluded from the requirements of the regulations, modifying the terms used when a select toxin is excluded from the regulations, clarifying those parts of the regulations that deal with temporary exemptions granted during periods of public health or agricultural emergencies, and adding language to specify that individuals not approved for unescorted access to registered space for activities not related to select agents or toxins (e.g., routine cleaning, maintenance, and repairs) would not have to be continuously escorted by an approved individual so long as those non-approved persons would not be able to gain access to select agents or toxins.
Health and Human Services Department -- Countermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury Table2014-Mar-312014-06102The Public Readiness and Emergency Preparedness Act (PREP Act) directs the Secretary of Health and Human Services (the Secretary), to establish a Countermeasures Injury Compensation Program (the Program) to provide ``timely, uniform, and adequate compensation'' to eligible individuals who sustain serious physical injuries or to certain survivors of individuals who die as a direct result of the use or administration of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. The Secretary has delegated authority to administer the Program to the Health Resources and Services Administration (HRSA). Through this regulation, the Secretary proposes a Table for pandemic influenza covered countermeasures identified by the Secretary in several PREP Act declarations. This regulation also includes proposed Table time intervals for the first symptom or manifestation of onset of injury, Table injury definitions, and requirements which define the terms and conditions included on the Table. These are considered part of the proposed Table.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of John Cunningham Virus Serological Reagents2014-Jan-232014-01216The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Health and Human Services Department -- Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products2013-Nov-132013-26799The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ``changes being effected'' (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA's review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder's CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the ``Highlights of Prescribing Information'' for drug products with labeling in the ``Physician Labeling Rule'' (PLR) format.
Health and Human Services Department -- Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products2013-Nov-042013-25956The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The proposed rule would require all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
Health and Human Services Department -- National Vaccine Injury Compensation Program2013-Jul-242013-17786The Secretary has made findings as to intussusceptions that can reasonably be determined in some circumstances to be caused or significantly aggravated by rotavirus vaccines. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will apply only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.
Health and Human Services Department -- Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program2013-Jul-232013-17547HHS is issuing this final rule to clarify how section 340B(e) of the Public Health Service Act (PHSA) will be implemented. The final rule applies section 340B(e) of the PHSA only to drugs transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA). The final rule also sets forth that it is the responsibility of the 340B covered entity to maintain auditable records that demonstrate compliance with the terms of the orphan drug exclusion requirements. This rule will provide clarity in the marketplace, maintain the 340B savings for newly- eligible covered entities, and protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act and intended by Congress.
Health and Human Services Department -- Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis2013-Jun-192013-14552The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Health and Human Services Department -- Use of Certain Symbols in Labeling2013-Apr-192013-09175The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a ``standardized symbol'') and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement ``Rx only'' on the labeling of prescription devices.
Health and Human Services Department -- Change of Address; Biologics License Applications; Technical Amendment2013-Apr-022013-07578The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.
Health and Human Services Department -- Medical Devices; Technical Amendment2013-Mar-262013-06826The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review2012-Oct-052012-24389In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is republishing that list. As a result of our review, we have added Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We have also removed from the list of HHS and overlap select agents and toxins, or excluded from compliance with part 73, the agents and toxins described in the Executive Summary. Further, in accordance with Executive Order 13546, ``Optimizing the Security of Biological Select Agents and Toxins in the United States,'' HHS/CDC has designated those select agents and toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence as ``Tier 1'' agents; established new security requirements for entities possessing Tier 1 agents, including the requirement to conduct pre- access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins; and made revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture (USDA) has made parallel regulatory changes.
Commerce Department -- Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act2012-Aug-062012-18530The Leahy-Smith America Invents Act (AIA) expands the scope of information that any party may cite in a patent file to include written statements of a patent owner filed in a proceeding before a Federal court or the United States Patent and Trademark Office (Office) regarding the scope of any claim of the patent, and provides for how such information may be considered in ex parte reexamination, inter partes review, and post grant review. The AIA also provides for an estoppel that may attach with respect to the filing of an ex parte reexamination request subsequent to a final written decision in an inter partes review or post grant review proceeding. The Office is revising the rules of practice to implement these post-patent provisions, as well as other miscellaneous provisions, of the AIA.
Commerce Department -- Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act2012-Jul-172012-16710The United States Patent and Trademark Office (Office) is revising the rules of patent practice to implement the preissuance submissions by third parties provision of the Leahy-Smith America Invents Act (AIA). This provision provides a mechanism for third parties to contribute to the quality of issued patents by submitting to the Office, for consideration and inclusion in the record of a patent application, any patents, published patent applications, or other printed publications of potential relevance to the examination of the application. A preissuance submission may be made in any non- provisional utility, design, and plant application, as well as in any continuing application. A third-party preissuance submission must include a concise description of the asserted relevance of each document submitted, and must be submitted within a certain statutorily specified time period. The third party must submit a fee as prescribed by the Director, and a statement that the submission complies with the statutory provision. The Office has also revised the rules of patent practice to make related aspects of the existing protest rule more consistent with the new rule implementing the preissuance submissions by third parties provision. Further, the Office is eliminating the provision providing for public use proceedings.
Health and Human Services Department -- Amendments to Sterility Test Requirements for Biological Products2012-May-032012-10649The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.
Health and Human Services Department -- Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis2012-Mar-192012-6518The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents2012-Mar-092012-5675The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.
Health and Human Services Department -- Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma2012-Jan-032011-33554The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.
Health and Human Services Department -- Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions2011-Dec-302011-33588The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.
Commerce Department -- Fee for Filing a Patent Application Other Than by the Electronic Filing System2011-Nov-152011-29462The Leahy-Smith America Invents Act provides an additional fee of $400 for applications not filed electronically. This final rule revises the rules of practice to include the fee for applications not filed electronically.
Health and Human Services Department -- Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection2011-Nov-072011-28724The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Yersinia species (spp.) detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the recommendation(s) of the panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device.
Health and Human Services Department -- Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule2011-Oct-072011-25858This document adopts the Countermeasures Injury Compensation Program Administrative Implementation Interim Final Rule as the final rule with technical amendments. The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this final rule to adopt the administrative policies, procedures, and requirements for the CICP set out in the interim final rule, which was published and effective on October 15, 2010. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary makes only minor technical amendments to the interim final rule, described below, and otherwise adopts the regulation as published on October 15, 2010.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review2011-Oct-032011-25427In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is proposing to amend and republish the list as required by the Bioterrorism Response Act. Further, on July 2, 2010, the President signed Executive Order 13546, ``Optimizing the Security of Biological Select Agents and Toxins in the United States'' that directed the Secretaries of HHS and Agriculture (USDA) to designate a subset of the select agents and toxins list (Tier 1) that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence; explore options for graded protection for these Tier 1 agents and toxins to permit tailored risk management practices based upon relevant contextual factors; and consider reducing the overall number of agents and toxins on the select agents and toxins list. E.O. 13546 also established the Federal Experts Security Advisory Panel (FESAP) to advise the HHS and USDA Secretaries on the designation of Tier 1 agents and toxins, reduction in the number of agents on the Select Agent List, establishment of suitability standards for those having access to Tier 1 select agents and toxins, and establishment of physical security and information security standards for Tier 1 select agents and toxins. The tiering of the select agents and toxins list will allow the application of more optimized security measures for those select agents or toxins which pose a higher risk to public health and safety should they be stolen or otherwise misused. In addition to addressing the FESAP recommendations in this Notice of Proposed Rulemaking (NPRM), we are also proposing to add two agents, Lujo and Chapare viruses to the list; adding definitions; and clarifying language concerning security, training, biosafety, and incident response. These changes will increase the usability of the select agents and toxins regulations as well as providing for enhanced program oversight.
Commerce Department -- Revision of Standard for Granting an Inter Partes Reexamination Request2011-Sep-232011-24464The United States Patent and Trademark Office (Office) is revising the rules of practice governing inter partes reexamination to implement a transition provision of the Leahy-Smith America Invents Act that changes the standard for granting a request for inter partes reexamination. The Office is also revising the rules governing inter partes reexamination to reflect the termination of inter partes reexamination effective September 16, 2012, which is provided for in the Act. The Leahy-Smith America Invents Act replaces inter partes reexamination by a new inter partes review process effective one year after the date of enactment of the Leahy-Smith America Invents Act (i.e., September 16, 2012), and provides that any request for inter partes reexamination filed on or after September 16, 2011, will not be granted unless the information presented in the request establishes that there is a reasonable likelihood that the requester will prevail with respect to at least one of the claims challenged in the request. This replaces the prior standard for granting a request for inter partes reexamination that required a substantial new question of patentability (SNQ) affecting any claim of the patent raised by the request. The Leahy-Smith America Invents Act does not revise the SNQ standard for granting an ex parte reexamination request.
Health and Human Services Department -- Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device2011-Aug-092011-20115The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum, and the devices that consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table2011-Jun-222011-15617On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to help the public identify clearly that these vaccines are covered by the VICP. The changes implemented here are authorized by section 2114(e) of the Public Health Service Act (the Act).
Health and Human Services Department -- Amendments to Sterility Test Requirements for Biological Products2011-Jun-212011-15346The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.
Health and Human Services Department -- Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program2011-May-202011-12423The ``Veterans Health Care Act of 1992,'' enacted section 340B of the Public Health Service Act (PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B implemented a drug pricing program by which manufacturers who participate in Medicaid are required to sell covered outpatient drugs to particular covered entities listed in the statute and must agree to charge a price that will not exceed the amount determined under a statutory formula. The manufacturer's obligation to sell at no greater than the ceiling price extends only to covered outpatient drugs and does not apply to inpatient drugs. Covered entities are required to ensure that drugs purchased under 340B are used only for outpatients. The Patient Protection and Affordable Care Act expanded the types of covered entities eligible to participate in the 340B Drug Pricing Program (340B Program) under the PHSA to include certain free standing cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children's hospitals. Of these entities, children's hospitals were already eligible to participate in the 340B drug pricing program under the Deficit Reduction Act of 2005. The Health Care and Education Reconciliation Act (HCERA) (the Patient Protection and Affordable Care Act and HCERA collectively hereinafter will be referred to as the ``Affordable Care Act''), as amended by the Medicare and Medicaid Extenders Act of 2010, contained a provision that limits the types of drugs that free standing cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals could obtain through the 340B Program. Under the changes made by the Affordable Care Act, orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program.
Health and Human Services Department -- Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection2011-May-182011-12088The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would establish as a special control limitations on the distribution of this device. FDA is publishing in this document the recommendations of the Panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability for comment of the draft guidance document that FDA proposes to designate as a special control for this device.
Health and Human Services Department -- Revision of the Requirements for Constituent Materials2011-Apr-132011-8885The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
Health and Human Services Department -- Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions2011-Mar-232011-6621The Food and Drug Administration (FDA) is proposing to amend the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery. Elsewhere in this issue of the Federal Register, FDA is announcing a final rule that classifies the ovarian adnexal mass assessment score test system into class II (special controls).
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System2011-Mar-232011-6620The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.
Health and Human Services Department -- Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Interim Final Rule2010-Oct-152010-25110The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this interim final rule with request for comments in order to establish administrative policies, procedures, and requirements for the CICP. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary is seeking public comments on this interim final rule.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table2010-Sep-132010-22745Through this proposed rule, the Secretary proposes to change the Vaccine Injury Table (Table) to create distinct and separate listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus (HPV) vaccines. The Table includes a list of covered vaccines under the National Vaccine Injury Compensation Program (VICP). The VICP provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This proposed rule is technical in nature. The four categories of vaccines described in this notice are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This document proposes to list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to make the Table more clear to the public.
Health and Human Services Department -- Revision of the Requirements for Constituent Materials2010-Mar-302010-7073The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under a section of the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of licensed biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
Health and Human Services Department -- Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays2009-Aug-259-20411The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.
Health and Human Services Department -- Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements2009-Aug-219-19682The Food and Drug Administration (FDA) is proposing to amend its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the proposed amendments would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins-Chapare virus2009-Aug-199-19737We are proposing to add Chapare virus to the list of HHS select agents and toxins. We are proposing this action because Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other currently regulated South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins; Proposed Addition of SARS-Associated Coronavirus (SARS-CoV)2009-Jul-139-16536The biological agents and toxins listed in Sec. 73.3 of Title 42 of the Code of Federal Regulations have been determined by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) to have the potential to pose a severe threat to public health and safety. We are now proposing to add SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We are proposing this action because (1) SARS-CoV can cause significant mortality, especially in the elderly; (2) the virus has the capability of easily being transmitted from human to human; (3) there is currently no vaccine or antiviral approved for the prevention or treatment of infections caused by the SARS-CoV virus; and (4) it has been documented that the virus may persist in the environment.
Health and Human Services Department -- Change of Addresses and Names; Technical Amendment2009-Mar-269-6795The Food and Drug Administration (FDA) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Central Document Room in Beltsville, MD; the relocation of certain CDER offices to the White Oak campus in Silver Spring, MD; and changes of the names of certain CDER organizational units. This action is editorial in nature and is intended to ensure the accuracy and clarity of the agency's regulations.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins2008-Oct-308-25883This document contains a technical correction to the list of select agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) published on October 16, 2008, in the Federal Register (73 FR 61363). This correction inserts ``Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight segments (Reconstructed 1918 Influenza virus)'' that was inadvertently omitted from the list of agents and toxins regulated by only HHS.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins2008-Oct-168-24623This document completes the biennial review and republication of the lists of biological agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA). Because USDA has chosen to no longer regulate ten biological agents and toxins which HHS still believes have the potential to pose a severe threat to public health and safety, we have moved those ten biological agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section of the select agent regulations. In a companion document published in this issue of the Federal Register, the USDA has established corresponding final rules regarding the select agents and toxins regulated only by the USDA, as well as those overlap select agents and toxins regulated by both agencies.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Removal of Separate Category for Vaccines Containing Live, Oral, Rhesus-Based Rotavirus From the Vaccine Injury Table2008-Oct-098-24017Through this interim final rule, the Secretary removes the category of vaccines containing live, oral, rhesus-based rotavirus, Category XII, from the Vaccine Injury Table (Table). The Table includes a list of covered vaccines under the National Vaccine Injury Compensation Program (VICP). The VICP provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This interim final rule is technical in nature. Even prior to the publication of this final rule, Category XII, the category that is being removed from the Table, only applied to vaccines that were administered on or before August 26, 2002. Given the applicable statute of limitations and the fact that Category XII limited its application to vaccines administered on or before August 26, 2002, the Secretary believes that no persons have claims that could be pursued under that category. Petitioners may still be able to file petitions relating to rotavirus vaccines under Category XI of the Table, the category of ``rotavirus vaccines,'' which does not include any associated injuries. Although the Secretary believes that the changes made in this interim final rule are noncontroversial as they do not affect the rights of any potential petitioners with the VICP, the Department is seeking public comment on this interim final rule. Written comments must be submitted on or before November 10, 2008. The Department will consider the comments received and will decide whether to amend the Table based on such comments.
Health and Human Services Department -- Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications2008-Jul-108-15608The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.
Health and Human Services Department -- Interstate Shipment of Etiologic Agents2008-Jan-238-1050HHS is removing Part 72 of Title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule eliminates duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS replaced those sections of Part 72 that deal with select biological agents and toxins with a new set of regulations found in Part 73 of Title 42. Removal of Part 72 alleviates confusion and reduces the regulatory burden with no anticipated adverse impact on public health and safety.
Health and Human Services Department -- Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile2007-Dec-287-25165The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with the requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency.
Health and Human Services Department -- Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use2007-Nov-087-21565The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.
Health and Human Services Department -- Revision of the Requirements for Live Vaccine Processing2007-Oct-187-20610The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins2007-Aug-2807-4233The select agents and toxins listed in 42 CFR part 73 include those regulated only by the U.S. Department of Health and Human Services (HHS) (42 CFR 73.3), as well as those overlap select agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) (42 CFR 73.4). In response to USDA's proposal to no longer regulate ten select agents and toxins currently listed as ``overlap'' agents and toxins, we are proposing to move those ten select agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section.
Health and Human Services Department -- Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”)2007-Aug-247-16607The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) ``lookback'' requirements for greater consistency with the HCV ``lookback'' requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' (the ``lookback'' guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.
Commerce Department -- Revision of Patent Fees for Fiscal Year 20072007-Aug-227-16574The United States Patent and Trademark Office (USPTO) (referred to as ``Office'' in this notice) is adjusting certain patent fee amounts to reflect fluctuations in the Consumer Price Index (CPI). Also, the Office is adjusting, by a corresponding amount, a few patent fee rates that track the affected fee amounts. The Director is authorized to adjust these fee amounts annually by the CPI to recover the higher costs associated with doing business. The USPTO is adjusting the patent fee amounts under the Consolidated Appropriations Act, 2005 (Consolidated Appropriations Act), which revised certain patent fee rates, and provided for a search fee and examination fee separate from the filing fee, during fiscal years 2005 and 2006; and continued in fiscal year 2007 under the revised Continuing Appropriations Resolution, 2007 (Continuing Appropriations Resolution). Legislation has been introduced that would extend the fee rate revisions in the Consolidated Appropriations Act. In the event legislation is not enacted to continue the patent fee amounts under the Consolidated Appropriations Act, the USPTO will be adjusting patent statutory fee rates that were in application prior to implementation of the Consolidated Appropriations Act. The prior fee rates, adjusted for CPI, will be effective for fiscal year 2008.
Health and Human Services Department -- Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule2007-Aug-167-15942The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health Insurance Policy2007-Jul-057-13039Subtitle 2 of Title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended (the Act), governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary), provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The final rule establishes the new method of calculating the average cost of a health insurance policy and determines the amount of the average cost of a health insurance policy to be deducted from the compensation award.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis2007-May-097-8871The Food and Drug Administration (FDA) is classifying gene expression profiling test systems for breast cancer prognosis into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 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 this device.
Commerce Department -- Revisions and Technical Corrections Affecting Requirements for Ex Parte2007-Apr-167-7202The United States Patent and Trademark Office (Office) is revising the rules of practice relating to ex parte and inter partes reexamination. The Office is designating the correspondence address for the patent as the correct address for all communications for patent owners in an ex parte reexamination or an inter partes reexamination, and simplifying the filing of reexamination papers by providing for the use of a single ``mail stop'' address for the filing of substantially all ex parte reexamination papers (such is already the case for inter partes reexamination papers). The Office is revising the rules to prohibit supplemental patent owner responses to an Office action in an inter partes reexamination proceeding without a showing of sufficient cause. Finally, the Office is making miscellaneous clarifying changes as to terminology and applicability of the reexamination rules. The Office is not implementing its proposal (that was set forth in the proposed rule making) to newly provide for a patent owner reply to a request for reexamination, prior to the Office's decision on the request.
Health and Human Services Department -- Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation2007-Mar-1207-1131The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue- based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).
Commerce Department -- Changes to Implement Priority Document Exchange Between Intellectual Property Offices2007-Jan-167-113The United States Patent and Trademark Office (Office) has established a 21st Century Strategic Plan to transform the Office into a more quality-focused, highly productive, responsive organization supporting a market-driven intellectual property system. One goal of the 21st Century Strategic Plan is the electronic exchange of information and documents between intellectual property offices. Consistent with this goal, the Office is revising the rules of practice to provide for the electronic transfer of certified copies of applications for which priority is claimed under the Paris Convention (priority applications) from other intellectual property offices with which the Office has negotiated priority document exchange agreements. The Office is also revising the rules of practice to permit applicants to request that the Office permit other participating intellectual property offices to electronically retrieve certified copies of United States patent applications without payment of a fee. This electronic exchange of copies of priority documents will benefit applicants by reducing the cost of ordering paper certified copies of priority applications for filing in other participating intellectual property offices, and will benefit participating intellectual property offices by reducing the administrative costs associated with handling paper copies of priority documents and scanning them into their electronic image record management systems.
Health and Human Services Department -- Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants2007-Jan-126-22329The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. FDA is proposing these actions as part of its continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of, bovine spongiform encephalopathy (BSE) and related human disease in the United States.
Health and Human Services Department -- Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays2007-Jan-107-119The Food and Drug Administration (FDA) is classifying quality control material for cystic fibrosis nucleic acid assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 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 this device.
Health and Human Services Department -- Interstate Shipment of Etiologic Agents2007-Jan-036-21723HHS proposes to remove Part 72 of Title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule will eliminate duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS replaced those sections of Part 72 that deal with select biological agents and toxins with a new set of regulations found in Part 73 of Title 42. HHS anticipates that removal of Part 72 will alleviate confusion and reduce the regulatory burden with no adverse impact on public health and safety.
Defense Department -- The Biological Defense Safety Program and Technical Safety Requirements2006-Dec-0806-9598The Department of the Army is removing its regulations concerning the biological Defense Safety Program and its requirements because it is now superseded through consolidation with other Army safety regulations into Army Regulation (AR) 385-10, Army Safety Program and does not affect the general public.
Commerce Department -- Clarification of Filing Date Requirements for Ex Parte2006-Aug-046-12600The United States Patent and Trademark Office (Office) is, in this final rule making, revising the rules of practice relating to the filing date requirements for ex parte and inter partes reexamination proceedings for consistency with the provisions of the patent statute governing ex parte and inter partes reexamination proceedings, and to permit the Office to have the full statutory three months to address a request for reexamination that is complete. The Office is specifically revising the rules to require that a request for ex parte reexamination or for inter partes reexamination must meet all the applicable statutory and regulatory requirements before a filing date is accorded to the request for ex parte reexamination or for inter partes reexamination.
Commerce Department -- Revision of Patent Fees for Fiscal Year 20072006-Jun-056-8682The United States Patent and Trademark Office (referred to as ``we'', ``us'', or ``our'' in this document) is proposing to adjust certain patent fee amounts to reflect fluctuations in the Consumer Price Index (CPI). Also, we are proposing to adjust, by a corresponding amount, a few patent fees that track the affected fees. The Director is authorized to adjust these fees annually by the CPI to recover the higher costs associated with doing business. We are proposing to adjust the patent fees under the Consolidated Appropriations Act, 2005 (Consolidated Appropriations Act), which revised certain patent fees, and provided for a search fee and examination fee that are separate from the filing fee, during fiscal years 2005 and 2006. Legislation has been introduced in the Congress that would extend the fee revisions in the Consolidated Appropriations Act. If, for any period during fiscal year 2007, the fee revisions in the Consolidated Appropriations Act are not in effect, then the fee adjustment would apply to the former fee amounts that were in place on October 1, 2004, to December 7, 2004, prior to the enactment of the Consolidated Appropriations Act.
Health and Human Services Department -- Smallpox Vaccine Injury Compensation Program: Administrative Implementation2006-May-2406-4762This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term ``child'' survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.
Health and Human Services Department -- Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table2006-May-2406-4761This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.
Commerce Department -- Revisions and Technical Corrections Affecting Requirements for Ex Parte2006-Mar-3006-2962The United States Patent and Trademark Office (Office) is proposing changes to the rules of practice relating to ex parte and inter partes reexamination. The Office is proposing to provide for a patent owner reply to a request for an ex parte reexamination or an inter partes reexamination prior to the examiner's decision on the request. The Office is also proposing to prohibit supplemental patent owner responses to an Office action in an inter partes reexamination without a showing of sufficient cause. The Office additionally proposes to designate the correspondence address for the patent as the correct address for all communications for patent owners in an ex parte reexamination or an inter partes reexamination, and to simplify the filing of reexamination papers by providing for the use of a single ``mail stop'' address for the filing of substantially all ex parte reexamination papers (such is already the case for inter partes reexamination papers). The Office is further proposing to make miscellaneous clarifying changes as to terminology and applicability of the reexamination rules. Comment Deadline Date: To be ensured of consideration, written comments must be received on or before May 30, 2006. No public hearing will be held.
Commerce Department -- Clarification of Filing Date Requirements for Ex Parte and Inter Partes Reexamination Proceedings2006-Feb-2306-1678The United States Patent and Trademark Office (Office) is revising the rules of practice relating to the filing date requirements for ex parte and inter partes reexamination proceedings for consistency with the provisions of the patent statute governing ex parte and inter partes reexamination proceedings. The Office is specifically revising the rules to require that a request for ex parte reexamination or for inter partes reexamination must meet all the applicable statutory requirements before a filing date is accorded to the request for ex parte reexamination or for inter partes reexamination.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins-Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments2005-Oct-2005-20946We are adding reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments to the list of HHS select agents and toxins. We are taking this action for several reasons. First the pandemic influenza virus of 1918-19 killed up to 50 million people worldwide, including an estimated 675,000 deaths in the United States. Also, the complete coding sequence for the 1918 pandemic influenza A H1N1 virus was recently identified, which will make it possible for those with knowledge of reverse genetics to reconstruct this virus. In addition, the first published study on a reconstructed 1918 pandemic influenza virus demonstrated the high virulence of this virus in cell culture, embryonated eggs, and in mice relative to other human influenza viruses. Therefore, we have determined that the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments have the potential to pose a severe threat to public health and safety.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins2005-Mar-1805-5216This document establishes a final rule regarding possession, use, and transfer of select agents and toxins. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture has established corresponding final rules designed to protect animal and plant health and animal and plant products.
Commerce Department -- Rules of Practice Before the Board of Patent Appeals and Interferences2004-Sep-3004-21966The United States Patent and Trademark Office (Office) is correcting a rule that appeared in the Federal Register of 12 August 2004 (69 FR 49960). The document revised the rules of practice before the Board of Patent Appeals and Interferences and made corresponding amendments to rules in 37 CFR part 1.
Commerce Department -- Rules of Practice Before the Board of Patent Appeals and Interferences2004-Aug-1204-17699The Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office consolidates and simplifies the rules governing practice before the Board of Patent Appeals and Interferences to reflect developments in case law, legislation, and administrative practice.
Health and Human Services Department -- Smallpox Vaccine Injury Compensation Program: Administrative Implementation2003-Dec-1603-30790The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program (``the Program''). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries. On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table (``the Table''). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use this table, as well as the procedures set out in this regulation, in deciding whether persons are eligible to receive benefits under the program. In this interim final rule, the Secretary is setting out the administrative policies, procedures, and requirements governing the program, as authorized by the SEPPA. The Secretary is seeking public comment on this interim final rule.
Commerce Department -- Rules of Practice Before the Board of Patent Appeals and Interferences2003-Nov-2603-29154The Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office proposes changes to the rules governing practice before the Board of Patent Appeals and Interferences to consolidate and simplify such rules and to reflect developments in case law, legislation, and administrative practice.
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins2003-Nov-0303-27659We are amending an interim final rule published on December 13, 2002, that established requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. The requirements were established to implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The December 2002 interim final rule established a phase-in period for certain requirements to allow entities to comply without causing disruption or termination of research or educational projects. The phase-in for entities that on February 7, 2003, were already conducting activities under a certificate of registration issued under 42 CFR 72.6, or already were lawfully possessing select agents and toxins, required entities applying for registration with the select agent program, and individuals requiring access to select agents and toxins, to undergo a security risk assessment by the Attorney General before November 12, 2003. The regulations also provided that an entity that on February 7, 2003, was not already conducting activities under a certificate of registration issued under 42 CFR 72.6, or was not already lawfully possessing select agents and toxins, would be eligible for registration to possess, use, or transfer select agents and toxins as soon as the entity met all of the applicable requirements of Part 73, including the requirement for the Attorney General to conduct a security risk assessment. We are now amending the applicability requirements to allow for the issuance of provisional registration certificates for all entities, and provisional grants of access for all individuals, from whom, prior to November 12, 2003, the Attorney General has received all of the information required by the Attorney General to conduct a security risk assessment if those entities and individuals otherwise meet all of the requirements of Part 73. This action is necessary to ensure that both ongoing and new research and educational efforts important to the national defense are not disrupted.
Health and Human Services Department -- Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table2003-Aug-2703-21906The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), Public Law 108-20, 117 Stat. 638, authorized the Secretary of Health and Human Services (the Secretary), through the establishment of the Smallpox Vaccine Injury Compensation Program (the Program), to provide benefits and/or compensation to certain persons who have sustained injuries as a result of the administration of smallpox covered countermeasures (including the smallpox vaccine) or as a result of vaccinia contracted through accidental vaccinia inoculations. The SEPPA directed the Secretary to establish, by interim final rule, a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. As mandated by law, the Secretary is establishing such a Smallpox (Vaccinia) Vaccine Injury Table (the Table) through this interim final rule. The Secretary is also establishing a set of Table Definitions and Requirements, which define the terms and conditions included on the Table and are to be read in conjunction with the Table. The Secretary is seeking public comment on the Table established through this interim final rule. At a later date, the Secretary will publish a companion final rule setting forth the administrative implementation of the Program. The public will then be afforded an additional opportunity to comment on the procedures set forth therein.
Health and Human Services Department -- Safety Reporting Requirements for Human Drug and Biological Products2003-Mar-1403-5204The Food and Drug Administration (FDA) is proposing to amend its pre- and postmarketing safety reporting regulations for human drug and biological products to implement definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and by the World Health Organization's (WHO's) Council for International Organizations of Medical Sciences (CIOMS); codify the agency's expectations for timely acquisition, evaluation, and submission of relevant safety information for marketed drugs and licensed biological products; require that certain information, such as domestic reports of medication errors, be submitted to the agency in an expedited manner; clarify certain requirements; and make other minor revisions. FDA is also proposing to amend its postmarketing annual reporting regulations for human drug and licensed biological products by revising the content for these reports. FDA is taking this action to strengthen its ability to monitor the safety of human drugs and biological products. The intended effect of these changes is to further worldwide consistency in the collection of safety information and submission of safety reports, increase the quality of safety reports, expedite FDA's review of critical safety information, and enable the agency to protect and promote public health. These proposed changes would be an important step toward global harmonization of safety reporting requirements and additional efforts are underway within the Department of Health and Human Services to harmonize the reporting requirements of U.S. Federal agencies (e.g., FDA and the National Institutes of Health (NIH) are continuing to work together to address the best ways to streamline information sharing and harmonize, to the extent possible, the safety reporting requirements of the two agencies).
Health and Human Services Department -- Possession, Use, and Transfer of Select Agents and Toxins2002-Dec-1302-31370This document establishes requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. This includes requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications. This document also contains delegations of authority to the Office of Inspector General concerning civil money penalties. The interim final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts. In addition and in accordance with the Agricultural Bioterrorism Protection Act of 2002, the Department of Agriculture is establishing, by separate regulation, standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. This action is necessary to protect animal and plant health, and animal and plant products.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table2002-Jul-2502-18827On July 13, 2001, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (the Table). The primary proposal made in the NPRM was that vaccines containing live, oral, rhesus-based rotavirus be added to the Table as a distinct category, with intussusception listed as a covered Table injury. This proposal was based upon the Secretary's determination that the condition of intussusception can reasonably be determined in some circumstances to be caused by vaccines containing live, oral, rhesus- based rotavirus. The Secretary is now making this amendment to the Table by final rule. The Secretary is also making additional amendments to the Table and to the Table's Qualifications and Aids to Interpretation (Qualifications and Aids), described below under SUPPLEMENTARY INFORMATION, as proposed in the NPRM. The changes implemented here are authorized by section 2114(c) and (e) of the Public Health Service Act (the Act).
Nuclear Regulatory Commission -- Medical Use of Byproduct Material2002-Apr-2402-9663The Nuclear Regulatory Commission (NRC) is amending its regulations regarding the medical use of byproduct material. This final rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those medical procedures that pose the highest risk to workers, patients, and the public, and to structure its regulations to be more risk-informed and more performance-based, consistent with the NRC's ``Strategic Plan for Fiscal Year 1997-Fiscal Year 2002.''
Health and Human Services Department -- Hematology and Pathology Devices; Reclassification of the Automated Differential Cell Counter2002-Jan-1402-792The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled ``Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA'' as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.
Health and Human Services Department -- Requirements for Facilities Transferring or Receiving Select Agents2001-Aug-3101-22128CDC administers regulations that govern the transfer of certain biological agents and toxins (``select agents''). These regulations require entities that transfer or receive select agents to register with CDC and comply with biosafety standards contained in the Third Edition of the CDC/NIH publication ``Biosafety in Microbiological and Biomedical Laboratories (``BMBL'').'' On October 28, 1999, CDC published a Notice of Proposed Rulemaking (``NPRM'') seeking both to revise the biosafety standards facilities must follow when handling select agents and to provide new biosecurity standards for such facilities. These new standards are contained in the Fourth Edition of BMBL, which the NPRM proposed to incorporate by reference, thereby replacing the Third Edition. No comments were received in response to this proposal. CDC is therefore amending its regulations to incorporate the Fourth Edition.
Health and Human Services Department -- National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table2001-Jul-1301-16814The Secretary has made findings as to a condition that can reasonably be determined in some circumstances to be caused by vaccines containing live, oral, rhesus-based rotavirus. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by adding to the Table vaccines containing live, oral, rhesus-based rotavirus as a distinct category, with intussusception listed as a covered Table injury. This proposal is based upon the recommendation by the Centers for Disease Control and Prevention (CDC) that Rotashield, the only U.S.-licensed rotavirus vaccine, no longer be administered to infants in the United States based on review of data indicating a strong association between Rotashield and intussusception in the 1 to 2 weeks following vaccination. The Secretary also proposes several additional amendments to the Table described below under SUPPLEMENTARY INFORMATION.
Health and Human Services Department -- Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation2001-Jan-1801-1048The Food and Drug Administration (FDA) is proposing to amend the biologics licensing regulations regarding confidentiality of information. The amendments would add provisions that would make available for public disclosure, and require submission for public disclosure of, certain data and information related to human gene therapy or xenotransplantation. The proposed regulation would apply specifically to the areas of human gene therapy and xenotransplantation because these areas of clinical research have the potential for unique public health risks and modification of the human genome. The proposed rule would provide for public disclosure of certain data and information related to an investigational new drug application (IND), to provide an opportunity for public education on, and discussion and consideration of, public health and safety issues. In addition, the proposed rule would require sponsors of clinical trials on human gene therapy or xenotransplantation to submit to FDA for public disclosure certain data and information that has been redacted to remove or obscure all information defined as confidential commercial or trade secret, or names and other personal identifiers of patients and certain other third parties.
Health and Human Services Department -- Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Companion to Direct Final Rule2000-Dec-1200-31587The Food and Drug Administration (FDA) is proposing to amend the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is proposing to remove the requirements that the products be sterile. FDA is taking this action because the requirement that these products be sterile is not necessary for the products to be safe, pure, and potent. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action final because the proposed changes are noncontroversial and FDA anticipates that it will receive no significant adverse comment.
Health and Human Services Department -- Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents2000-Dec-1200-31586The Food and Drug Administration (FDA) is amending the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is amending the regulations to remove the requirements that the products be sterile. FDA is publishing this direct final rule because the requirement that these products be sterile is not necessary for the products to be safe, pure, and potent. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment that warrants terminating the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule.
Health and Human Services Department -- Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems2000-Nov-2200-29841The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled ``Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications.'' Elsewhere in this issue of the Federal Register, FDA is announcing the availability of this guidance document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.
Health and Human Services Department -- Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (“Lookback”)2000-Nov-1600-28907The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that blood and blood components at increased risk of transmitting hepatitis C virus (HCV) infection have been collected from a donor who tested repeatedly reactive for evidence of HCV infection at a later date. This proposed rule would require blood establishments to quarantine prior collections from such a donor, perform further testing on the donor, and notify transfusion recipients, as appropriate, when such a donor is identified at the time of a repeat donation or after performing a review of historical testing records to identify donations at increased risk of transmitting HCV. In addition, FDA is proposing to extend the record retention period to 10 years to create opportunities for disease prevention many years after recipient exposure to such a donor. This action is taken as part of FDA's ``Blood Initiative'' to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the licensing and regulation of blood products. This proposed rule is intended to help ensure the continued safety of the blood supply and to help ensure that information is provided to consignees and to prior recipients of blood and blood components from a donor whose subsequent donation tests positive for antibody to HCV or otherwise is determined to have been at increased risk of transmitting HCV.
Health and Human Services Department -- Biological Products: Reporting of Biological Product Deviations in Manufacturing2000-Nov-0700-28133The Food and Drug Administration (FDA) is amending the regulation requiring licensed manufacturers of biological products to report errors and accidents in manufacturing that may affect the safety, purity, or potency of a product. FDA also is amending the current good manufacturing practice (CGMP) regulations for blood and blood components to require establishments involved in the manufacture of blood and blood components, including licensed manufacturers, unlicensed registered establishments and transfusion services, to report biological product deviations in manufacturing. The final rule requires licensed manufacturers, unlicensed registered blood establishments, and transfusion services who had control over the product when a deviation occurred to report to FDA the biological product deviation if the product has been distributed. The final rule also establishes a 45-day reporting period. FDA is issuing the final rule as part of a retrospective review under Executive Order 12866 of significant FDA regulations to improve the effectiveness of FDA's regulatory program.
Health and Human Services Department -- Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports2000-Oct-3000-27731The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Health and Human Services Department -- Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment2000-Oct-0600-25705The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently omitted. This action is being taken to improve the accuracy of the regulations.
Health and Human Services Department -- Administrative Practices and Procedures; Good Guidance Practices2000-Sep-1900-23887The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act codified certain parts of the agency's current ``Good Guidance Practices'' (GGP's) and directed the agency to issue a regulation consistent with the act that specifies FDA's policies and procedures for the development, issuance, and use of guidance documents. The intended effect of this regulation is to make the agency's procedures for development, issuance, and use of guidance documents clear to the public.
Health and Human Services Department -- Hematology and Pathology Devices; Reclassification; Restricted Devices; OTC Test Sample Collection Systems for Drugs of Abuse Testing2000-Apr-0700-8598The Food and Drug Administration (FDA) is reclassifying over- the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.
Treasury Department -- Kerosene Tax; Aviation Fuel Tax; Taxable Fuel Measurement and Reporting; Tax on Heavy Trucks and Trailers; Highway Vehicle Use Tax2000-Mar-3100-7351This document contains final regulations relating to the kerosene and aviation fuel excise taxes, the tax on the use of certain highway vehicles, and the tax on the first retail sale of certain tractors and truck, trailer, and semitrailer chassis and bodies (highway vehicles). The regulations relating to kerosene affect the tax liability of certain refiners, terminal operators, and persons that sell, buy, or use kerosene. The regulations relating to aviation fuel affect certain producers and retailers of aviation fuel. The regulations relating to the taxes on highway vehicles affect vehicle manufacturers, dealers, and owners.
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