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Medical devices; clinical chemistry and clinical toxicology devices; classification of the cardiac allograft gene expression profiling test systems.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test systems 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: Cardiac Allograft Gene Expression Profiling Test Systems." FDA classified 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 w...
Source: Fed Regist - October 21, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medical devices; immunology and microbiology devices; classification of respiratory viral panel multiplex nucleic acid assay. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls). The special controls that will apply to the device are three guidance documents entitled: "Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay," as applicable, "Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays," and as applicable,"Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus S...
Source: Fed Regist - October 9, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Interim final rules prohibiting discrimination based on genetic information in health insurance coverage and group health plans. Interim final rules with request for comments.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This document contains interim final rules implementing sections 101 through 103 of the Genetic Information Nondiscrimination Act of 2008. These provisions prohibit discrimination based on genetic information in health insurance coverage and group health plans. PMID: 19877372 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - October 7, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Revised medical criteria for evaluating malignant neoplastic diseases. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: We are revising some of the criteria in the Listing of Impairments (the listings) that we use to evaluate claims involving malignant neoplastic diseases (cancer) \1\ under titles II and XVI of the Social Security Act (Act). The revisions reflect our adjudicative experience, advances in medical knowledge, diagnosis, and treatment, and public comments we received in response to a Notice of Proposed Rulemaking (NPRM). PMID: 19877368 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - October 6, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Schedule of controlled substances; placement of fospropofol into schedule IV. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance fospropofol, including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule IV of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of schedule IV will be applicable to the manufacture, distribution, dispensing, importation, and exportation of fospropofol and products containing fospropofol. PMID: 19877370 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - October 6, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; limitation on recoupment of provider and supplier overpayments. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This final rule implements a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) which prohibits recouping Medicare overpayments from a provider or supplier that seeks a reconsideration from a Qualified Independent Contractor (QIC). This provision changes how interest is to be paid to a provider or supplier whose overpayment is reversed at subsequent administrative or judicial levels of appeal. This final rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in our obligation to pay...
Source: Fed Regist - September 15, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Presumption of service connection for osteoporosis for former prisoners of war. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Department of Veterans Affairs (VA) is amending its adjudication regulations to establish a presumption of service connection for osteoporosis for former Prisoners of War (POWs) who were detained or interned for at least 30 days and whose osteoporosis is at least 10 percent disabling. The amendment implements a decision by the Secretary to establish such a presumption based on scientific studies. VA is additionally amending its adjudication regulations to establish a presumption of service connection for osteoporosis for POWs who were detained or interned for any period of time, have a diagnosis of postt...
Source: Fed Regist - August 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medication Prescribed by Non-VA Physicians. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This document amends and adopts an interim final rule that governs the provision of medications to veterans when medication is prescribed by physicians who are not employees of nor are they providing care under contract with the Department of Veterans Affairs (VA). In a document published in the Federal Register on July 25, 2003, VA issued an interim final rule establishing a temporary program while also maintaining the program that it had in place before the interim final rule. Because the need cited in the interim final rule has abated and because the provisions added by the interim final rule were self-li...
Source: Fed Regist - August 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; changes to the hospital inpatient prospective payment system for acute care hospitals and fiscal year 2010 rates; and changes to the long-term care hospital prospective payment system and rate years 2010 and 2009 rates. Final rules and interim final rule with comment period.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the TMA, Abstinence Education, and QI Program Extension Act of 2007, the Medicare Improvements for Patients and Providers Act of 2008, and the American Recovery and Reinvestment Act of 2009. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care h...
Source: Fed Regist - August 26, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Microbiology devices; reclassification of Herpes simplex virus types 1 and 2 serological assays. Direct final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The 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 correctin...
Source: Fed Regist - August 24, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Patient safety and quality improvement: civil money penalty inflation adjustment. Direct final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Department of Health and Human Services amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are amending the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990. We are using direct final rulemaking for this action because we expect that there will be no significant adverse comment on the rule. PMID: 19827227 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - August 24, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Charging for investigational drugs under an investigational new drug application. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and t...
Source: Fed Regist - August 12, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Expanded access to investigational drugs for treatment use. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients wi...
Source: Fed Regist - August 12, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities for FY 2010; minimum data set, version 3.0 for skilled nursing facilities and Medicaid nursing facilities. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2010. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures related to the implementation of case-mix refinements in January 2006. It also discusses the results of our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification project, as well as a new Resource Utilization Groups, version 4 case-mix classification model for FY 2011 that will...
Source: Fed Regist - August 10, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; inpatient rehabilitation facility prospective payment system for federal fiscal year 2010. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This final rule updates the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2010 (for discharges occurring on or after October 1, 2009 and on or before September 30, 2010) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in comput...
Source: Fed Regist - August 6, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; hospice wage index for fiscal year 2010. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This final rule will set forth the hospice wage index for fiscal year 2010. The final rule adopts a MedPAC recommendation regarding a process for certification and recertification of terminal illness. In addition, this final rule will also revise the phase-out of the wage index budget neutrality adjustment factor (BNAF), with a 10 percent BNAF reduction in FY 2010. The BNAF phase-out will continue with successive 15 percent reductions from FY 2011 through FY 2016. PMID: 19691168 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - August 5, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Dental devices: classification of dental amalgam, reclassification of dental mercury, designation of special controls for dental amalgam, mercury, and amalgam alloy. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy." This action is being taken to establish sufficient regulatory controls to...
Source: Fed Regist - August 3, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. PMID: 19655468 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - July 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

New drug applications and abbreviated new drug applications; technical amendment. final rule; technical amendment.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to correct the address for the Orange Book Staff in the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations. PMID: 19653378 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - July 23, 2009 Category: American Health Tags: Fed Regist Source Type: journals

TRICARE: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) changes included in the John Warner National Defense Authorization Act (NDAA) for fiscal year (FY) 2007; authorization of forensic examinations. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This final rule implements section 701 of the John Warner National Defense Authorization Act for FY 2007, Public Law 109-364. Section 701 amends Title 10 of the United States Code (U.S.C.), Chapter 55, Section 1079(a) by authorizing coverage for forensic examinations following a sexual assault or domestic violence for eligible beneficiaries. This authorizes forensic examinations provided in civilian health care facilities (e.g., civilian rape crisis facilities) following sexual assault or domestic violence, which is consistent with the services that are authorized in Military Medical Treatment Facilities for...
Source: Fed Regist - July 16, 2009 Category: American Health Tags: Fed Regist Source Type: journals

TRICARE: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) changes included in the John Warner National Defense Authorization Act (NDAA) for fiscal year (FY) 2007; authorization of forensic examinations.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This part establishes policy, assigns responsibilities and provides procedures for the regulation of the selection, accountability, training, equipping, and conduct of personnel performing private security functions under a covered contract during contingency operations. It also assigns responsibilities and establishes procedures for incident reporting, use of and accountability for equipment, rules for the use of force, and a process for administrative action or the removal, as appropriate, of PSCs and PSC personnel. For the Department of Defense, this IFR supplements DoD Instruction 3020.41, "Contractor Pe...
Source: Fed Regist - July 16, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Elimination of requirement for prior signature consent and pre-and post-test counseling for HIV testing. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This document adopts, without change, the proposed rule published in the Federal Register on December 29, 2008, updating informed consent requirements related to testing for the Human Immunodeficiency Virus (HIV) for Veterans receiving health care from the Department of Veterans Affairs (VA). This final rule is in accordance with related provisions of the Veteran's Mental Health and Other Care Improvements Act of 2008. The final rule eliminates the regulatory requirement for written informed consent for HIV testing and specific pre- and post-test counseling of Veteran patients. VA will implement this rule th...
Source: Fed Regist - July 15, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medical use of byproduct material--authorized user clarification. Direct final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to clarify that individuals who do not need to comply with the training and experience requirements as described in the applicable regulations for the medical use of byproduct material (i.e., are "grandfathered") may serve as preceptors and work experience supervisors for individuals seeking recognition on NRC licenses for the same medical uses of byproduct material. The regulations that govern the medical use of byproduct material were amended in their entirety in 2002 and again in 2005. Currently, individuals who were identified on an...
Source: Fed Regist - July 13, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Prevention of Salmonella enteritidis in shell eggs during production, storage, and transportation. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is issuing a final rule that requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance with the rule and to register with FDA. FDA is taking this action because SE is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are a primary source of human SE infections. The final rule will reduce SE-associated illnesses and deaths by re...
Source: Fed Regist - July 8, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA): preauthorization of durable medical equipment. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This document amends the Department of Veterans Affairs (VA) medical regulations for the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) preauthorization section by increasing the dollar ceiling for purchase or rental of durable medical equipment (DME) from $300 to $2,000. PMID: 19588579 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - June 30, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicaid program: rescission of School-Based Administration/Transportation final rule, Outpatient Hospital Services final rule, and partial rescission of Case Management Interim final rule. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This rule finalizes our proposal to rescind the December 28, 2007 final rule entitled, "Elimination of Reimbursement under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School;" the November 7, 2008 final rule entitled, "Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition;" and certain provisions of the December 4, 2007 interim final rule entitled, "Optional State Plan Case Management Services." These regulations have been the subject of Congressional moratoria and have not yet b...
Source: Fed Regist - June 29, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicaid program; health care-related taxes. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This rule finalizes our proposal to delay enforcement of certain clarifications regarding standards for determining hold harmless arrangements in the final rule entitled, "Medicaid Program; Health Care-Related Taxes" from the expiration of a Congressional moratorium on enforcement from July 1, 2009 to June 30, 2010. PMID: 19588577 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - June 29, 2009 Category: American Health Tags: Fed Regist Source Type: journals

International Conference on Harmonisation; guidance on Q8(R1) Pharmaceutical Development; addition of annex; availability. Notice.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q8(R1) Pharmaceutical Development." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH Q8(R1) guidance includes the previously published parent guidance entitled "Q8 Pharmaceutical Development" (Q8 parent guidance) (71 FR 29344; May 22, 2006) and a newly added annex. The annex provides further clarification of key concepts outlined in the Q8 parent guidance and describes the principle...
Source: Fed Regist - June 8, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; revisions to FY 2009 Medicare severity-long-term care diagnosis-related group (MS-LTC-DRG) weights. Interim final rule with comment period.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This interim final rule with comment period implements revised Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) relative weights for payment under the long-term care hospital (LTCH) prospective payment system (PPS) for federal fiscal year (FY) 2009. We are revising the MS-LTC-DRG relative weights for FY 2009 due to the misapplication of our established methodology in the calculation of the budget neutrality factor. The revised FY 2009 MS-LTC-DRG relative weights are effective for the remainder of FY 2009 (that is, from June 3, 2009 through September 30, 2009). PMID: 19507331 [PubMed ...
Source: Fed Regist - June 2, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Beverages: bottled water. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determi...
Source: Fed Regist - May 28, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Schedules of controlled substances: placement of lacosamide into schedule V. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: With the issuance of this final rule, the Deputy Administrator of the DEA places the substance lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy-propionamide] and any material, compound, mixture, or preparation which contains any quantity of lacosamide into schedule V of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of schedule V will be applicable to the manufacture, distribution, dispensing, importation and exportation of lacosamide. PMID: 19507328 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - May 20, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Schedules of controlled substances: placement of tapentadol into schedule II. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance tapentadol, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, into schedule II of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of schedule II will be applicable to the manufacture, distribution, dispensing, importation, and exportation of tapentadol and products containing tapentadol. PMID: 19507329 [P...
Source: Fed Regist - May 20, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Expansion of enrollment in the VA health care system.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This document amends the Department of Veterans Affairs (VA) medical regulations regarding enrollment in the VA health care system. In particular, it establishes additional sub-priorities within enrollment priority category 8 and provides that beginning on the effective date of the rule, VA will begin enrolling priority category 8 veterans whose income exceeds the current means test and geographic means test income thresholds by 10 percent or less. PMID: 19507327 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - May 14, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Presumptive service connection for disease associated with exposure to certain herbicide agents: AL amyloidosis. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This document amends the Department of Veterans Affairs (VA) adjudication regulations concerning presumptive service connection for a certain disease based on the most recent National Academy of Sciences (NAS) Institute of Medicine committee report, "Veterans and Agent Orange: Update 2006" (Update 2006). This amendment is necessary to implement a decision of the Secretary of Veterans Affairs that there is a positive association between exposure to herbicides used in the Republic of Vietnam during the Vietnam era and the subsequent development of AL amyloidosis. The intended effect of this amendment is to est...
Source: Fed Regist - May 6, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA). PMID: 19507324 [PubMed - indexed for MEDLINE]...
Source: Fed Regist - April 28, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Per diem for nursing home care of veterans in state homes. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Department of Veterans Affairs (VA) amends its regulations which set forth a mechanism for paying per diem to State homes providing nursing home care to eligible veterans. More specifically, we are updating the basic per diem rate, implementing provisions of the Veterans Benefits, Health Care, and Information Technology Act of 2006, and making several other changes to better ensure that veterans receive quality care in State homes. PMID: 19507325 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - April 28, 2009 Category: American Health Tags: Fed Regist Source Type: journals

International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4B on Microbiological Examination of nonsterile products: Tests for Specified Microorganisms General Chapter; availability. Notice.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." PMID: 19507320 [PubMed - index...
Source: Fed Regist - April 7, 2009 Category: American Health Tags: Fed Regist Source Type: journals

International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization ...
Source: Fed Regist - April 7, 2009 Category: American Health Tags: Fed Regist Source Type: journals

International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4A on Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter; availability. Notice.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." PMID: 19507322 [PubMed - index...
Source: Fed Regist - April 7, 2009 Category: American Health Tags: Fed Regist Source Type: journals

International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for use in the International Conference on Harmonisation Regions; Annex 4C on Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter; availability. Notice.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." PMID: 19507323 [PubMed - index...
Source: Fed Regist - April 7, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Interim final rule with request for comments.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Ryan Haight Online Pharmacy Consumer Protection Act, which was enacted on October 15, 2008, amended the Controlled Substances Act and Controlled Substances Import and Export Act by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. DEA is hereby issuing an interim rule to amend its regulations to implement the legislation and is requesting comments on the interim rule. PMID: 19507319 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - April 5, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicaid program; state flexibility for Medicaid benefit packages.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This action temporarily delays the effective date of the December 3, 2008 final rule entitled, "Medicaid Program: State Flexibility for Medicaid Benefit Packages" (73 FR 73694) until December 31, 2009. In addition, this action reopens the comment period on the policies set out in the December 3, 2008 final rule, and specifically solicits comments on the effect of certain provisions of the Children's Health Insurance Program Reauthorization Act of 2009. PMID: 19418642 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - April 2, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare and Medicaid programs; approval of the Joint Commission for continued deeming authority for hospices. Final notice.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This final notice announces the approval of a deeming application from the Joint Commission for continued recognition as a national accreditation program for hospices that request participation in the Medicare or Medicaid programs. PMID: 19418640 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - March 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicaid program; premiums and cost sharing. Final rule; delay of effective date and reopening of comment period.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This action temporarily delays the effective date of the November 25, 2008 final rule entitled, Medicaid Program; Premiums and Cost Sharing" (73 FR 71828) until December 31, 2009. In addition, this action reopens the comment period on the policies set out in the November 25, 2008 final rule, and specifically solicits comments on the effect of certain provisions of the American Recovery and Reinvestment Act of 2009. PMID: 19418641 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - March 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we receiv...
Source: Fed Regist - March 6, 2009 Category: American Health Tags: Fed Regist Source Type: journals

New drug applications and abbreviated new drug applications; technical amendment. Final rule; technical amendment.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications and to correct an inaccurate cross-reference. This action is being taken to ensure accuracy and clarity in the agency's regulations. PMID: 19418639 [PubMed - indexed for MEDLINE] (Source: Fed Regist)
Source: Fed Regist - March 6, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; changes to the Medicare claims appeal procedures; continuation of effectiveness and extension of timeline for publication of final rule. Interim final rule with comment period; continuation of effectiveness and extension of timeline for publication of final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This notice announces the continuation of effectiveness of a Medicare interim final rule with comment period and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act (the "regular timeline") or, if applicable, at the end of each succeeding 1-year extension to the regular timeline, if prior to the expiration of the timeline, the Secretary publishes in the Federal...
Source: Fed Regist - February 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicaid program; premiums and cost sharing. Final rule; delay of effective data and reopening of comment period.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: In accordance with the memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff, entitled "Regulatory Review Plan," this action temporarily delays for 60 days the effective date of the final rule entitled "Medicaid Program; Premiums and Cost Sharing" (73 FR 71828). The temporary 60-day delay in effective date is necessary to give Department officials the opportunity for further review and consideration of new regulations. In addition, this action reopens the comment period on the policies set out in the November 25, 2008 final rule. PMID: 19385112 [PubMed - indexed for MEDLI...
Source: Fed Regist - January 27, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Requirements for submission of bioequivalence data; final rule. Final rule.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product m...
Source: Fed Regist - January 16, 2009 Category: American Health Tags: Fed Regist Source Type: journals

Medicare program; changes to the competitive acquisition of certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) by certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Interim final rule with comment period.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Authors: This interim final rule with comment period implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program. Specifically, this rule: Implements certain MIPPA provisions that delay implementation of Round 1 of the program; requires CMS to conduct a second Round 1 competition (the "Round 1 rebid") in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing fee...
Source: Fed Regist - January 16, 2009 Category: American Health Tags: Fed Regist Source Type: journals