Department of Health and Human Services November 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 277 of 277
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the requirement of special controls for class II devices. This draft guidance is not final nor is it in effect at this time.
Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection
The 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.
Product Shortage Report; Availability; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of a medical product shortage report entitled ``A Review of FDA's Approach to Medical Product Shortages.'' The Agency is making the report available by placing it in the docket opened for a previous public workshop on drug shortages. The report discusses the Agency's approach to product shortages, particularly those products regulated by the FDA Center for Drug Evaluation and Research (CDER). FDA requests comments, until December 23, 2011, on the report and its recommendations, including whether there are additional suggestions for recommendations and how we should prioritize work on these recommendations.
Statement of Organization, Functions, and Delegations of Authority; Office of the Deputy Assistant Secretary for Administration
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Administration (ODASA). This reorganization renames the Office of Management Resources (OMR) to the Office of Workforce Planning and Development. In addition, it realigns the ethics, facilities, security and travel functions formerly located in OMR to the Immediate Office of the Deputy Assistant Secretary for Administration.
Proposed Eligibility Criteria for the Centers of Excellence Program in Health Professions Education for Under-Represented Minority Individuals
This notice requests comments on proposed eligibility criteria for the Centers of Excellence (COE) program in health professions education for under-represented minority (URM) individuals (See Title VII, Section 736 of the Public Health Service Act, 42 U.S.C. 293 (2011) as amended by the Patient Protection and Affordable Care Act, Public Law 111-148, Sec. 5401 (2010)). When finalized, these eligibility criteria will be used to determine the eligibility of designated health professions schools to apply for COE funding in fiscal year (FY) 2012 and subsequent fiscal years. Funding is dependent on the availability of appropriated funds for the COE program. The designated health professions schools are schools of allopathic medicine, osteopathic medicine, dentistry, pharmacy, and graduate programs in behavioral or mental health. This does not apply to Historically Black Colleges and Universities (HBCUs) eligible to establish a COE, under PHS Act section 736(c)(2).
Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS'' (Blueprint). The draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS). FDA seeks stakeholder input on the document. After comments are received, FDA will revise the Blueprint as appropriate, incorporate it into the Opioid REMS when it is approved, and post it on FDA's Web site for use by CE providers.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2011
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Jayant Jagannathan, M.D., University of Virginia Medical Center: Based on the report of an investigation conducted by the University of Virginia (UVA) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Jayant Jagannathan, former Resident Physician at UVA Medical Center, engaged in research misconduct by plagiarizing research supported by National Institutes of Health (NIH) research and training awards and by NIH intramural research funds from the National Institute of Neurological Disorders and Stroke (NINDS), Surgical Neurosurgery Branch (NSB), and from the National Institute of Dental and Craniofacial Research (NIDCR). ORI found that the Respondent engaged in research misconduct by including, in five publications, large amounts of text and an illustration that he plagiarized from publications supported by the following NIH grant awards: T32 CA09677, P01 HL024136, R01 HL059157, P50 CA090270, M01 RR01346, R01 CA075979, R01 DK064169, R01 NS027544, R01 NS052406, and K08 NS002197,\1\ and by intramural funds from the Surgical Neurosurgery Branch, NINDS, and from NIDCR.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be conducted as a telephone conference call. The meeting will be open to the public through a conference call phone number.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Ames Laboratory at Iowa State University as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Y-12 facility in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from W.R. Grace and Company in Curtis Bay, Maryland, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2012
This final rule sets forth updates to the home health prospective payment system (HH PPS) rates, including: the national standardized 60-day episode rates; the national per-visit rates; and the low utilization payment amount (LUPA) under the Medicare PPS for home health agencies effective January 1, 2012. This rule applies a 1.4 percent update factor to the episode rates, which reflects a 1 percent reduction applied to the 2.4 percent market basket update factor, as mandated by the Affordable Care Act. This rule also updates the wage index used under the HH PPS, and further reduces home health payments to account for continued nominal growth in case-mix which is unrelated to changes in patient health status. This rule removes two hypertension codes from the HH PPS case-mix system, thereby requiring recalibration of the case-mix weights. In addition, the rule implements two structural changes designed to decrease incentives to upcode and provide unneeded therapy services. Finally, this rule incorporates additional flexibility regarding face-to-face encounters with providers related to home health care.
Temporary Certification Program; Notice of Extension
This notice announces the decision made by the National Coordinator for Health Information Technology (the National Coordinator) to extend the Temporary Certification Program.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Meeting of the Advisory Committee on Blood Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.
Notice of the Revised Priority List of Hazardous Substances That Will Be the Subject of Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priorities List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA as amended also requires that the Priority List of Hazardous Substances be revised periodically. This announcement provides notice that a revised Priority List of 275 Hazardous Substances has been developed and is now available for download. CERCLA as amended also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list. Thus, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP).
Agency Information Collection Activities; Proposed Collection; Comment Request; Implementation of the Food and Drug Administration Amendments Act of 2007
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirement established by Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) that device establishments must submit registration and listing information by electronic means, using FDA Form 3673, unless the Secretary of the Department of Health and Human Services (the Secretary) grants them a waiver from the electronic submission requirement.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
This notice advises the public of the published lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of September 1, 2011, available on the Health Resources and Services Administration (HRSA) Web site at https:// bhpr.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2012
This notice announces the $523 calendar year (CY) 2012 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid programs or Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2012 and on or before December 31, 2012.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a Web meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The Web meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https://www.healthcare.gov/prevention/nphpphc/advisorygrp/inde x.html
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities; Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``MEPS Cancer Self Administrated Questionnaire.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision), VICH GL18(R); Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (100) entitled ``Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision)'' VICH GL18(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers of products derived from treated food producing animals. It is intended to assist in developing new animal drug applications (referred to as marketing applications in this guidance) submitted to the European Union, Japan, and the United States.
Implementation of Section 2695 (42 U.S.C. 300ff-131) of Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements
The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87) addresses notification procedures for medical facilities and state public health officers and their designated officers regarding exposure of emergency response employees (EREs) to potentially life- threatening infectious diseases. The Secretary of Health and Human Services (Secretary) has delegated authority to the Director of the Centers for Disease Control and Prevention (CDC) to issue a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which EREs may be exposed in responding to emergencies (including a specification of those infectious diseases that are routinely transmitted through airborne or aerosolized means); guidelines describing circumstances in which employees may be exposed to these diseases; and guidelines describing the manner in which medical facilities should make determinations about exposures. On December 13, 2010, CDC invited comment on a draft list of covered infectious diseases and both sets of guidelines (75 FR 77642). In consideration of the comments received, this notice sets forth CDC's final list of diseases, final guidelines describing circumstances under which exposure to listed diseases may occur, and final guidelines for determining whether an exposure to the listed diseases has occurred.
Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations
This final rule implements section 3022 of the Affordable Care Act which contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, and be eligible for additional payments if they meet specified quality and savings requirements.
Medicare Program; Final Waivers in Connection With the Shared Savings Program
This interim final rule with comment period establishes waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the Shared Savings Program), including ACOs participating in the Advance Payment Initiative. Section 1899(f) of the Act, as added by the Affordable Care Act, authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act.
Medicare Program; Advanced Payment Model
This notice announces the testing of the Advance Payment Model for certain accountable care organizations participating in the Medicare Shared Savings Program scheduled to begin in 2012, and provides information about the model and application process.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of “Health Care Providers' Responses to Medical Device Labeling”
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on this proposed information collection ``Health Care Providers' Responses to Medical Device Labeling.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice, published in the Federal Register of May 23, 2011 (76 FR 29767), entitled ``Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Request for Comments.'' In that document, FDA opened a docket and requested information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Cosmetic Microbiological Safety Issues; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Cosmetic Microbiological Safety Issues.'' The purpose of the public meeting is to provide stakeholders an opportunity to present information regarding cosmetic microbiological safety and to suggest areas for the possible development of FDA guidance documents. FDA is seeking information regarding microbiological testing of cosmetics; types of preservative systems and how to test their efficacy; the identity and prevalence of microorganisms, including antibiotic-resistant strains, that pose specific health risks in finished products; routes of exposure to microorganisms and the corresponding infective doses; product and packaging characteristics that affect microbial growth and risk of infection; particular subpopulations that may be at greater risk of infection when using different cosmetic products; the occurrence of adverse events associated with microbial contamination of cosmetics; and any other issues relevant to the microbiological safety of cosmetics.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Panels
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain device panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the National Mammography Quality Assurance Advisory Committees
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Medicare Program; Part A Premiums for CY 2012 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2012. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2012, for these individuals will be $451. The reduced premium for certain other individuals as described in this notice will be $248.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2012
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2012 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2012, the inpatient hospital deductible will be $1,156. The daily coinsurance amounts for CY 2012 will be(1) $289 for the 61st through 90th day of hospitalization in a benefit period; (2) $578 for lifetime reserve days; and (3) $144.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2012
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2012. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2012 are $199.80 for aged enrollees and $192.50 for disabled enrollees. The standard monthly Part B premium rate for 2012 is $99.90, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2011 standard premium rate was $115.40) The Part B deductible for 2012 is $140.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage.
Common Formats for Patient Safety Data Collection and Event Reporting
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow health care providers to voluntarily collect and submit standardized information regarding patient safety events. The purpose of this notice is to announce the availability of a new beta version Common Format for Venous Thromboembolism (VTE) for public review and comment.
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