Department of Health and Human Services August 2012 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-November 14, 2012
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 14, 2012. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of ventricular assist devices (VADs), a clinical strategy for the management of heart failure. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers
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. Some of the changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. These changes will be applicable to discharges occurring on or after October 1, 2012, unless otherwise specified in this final rule. We also are updating the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of-increase limits will be effective for cost reporting periods beginning on or after October 1, 2012. We are updating 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) and implementing certain statutory changes made by the Affordable Care Act. Generally, these changes will be applicable to discharges occurring on or after October 1, 2012, unless otherwise specified in this final rule. In addition, we are implementing changes relating to determining a hospital's full-time equivalent (FTE) resident cap for the purpose of graduate medical education (GME) and indirect medical education (IME) payments. We are establishing new requirements or revised requirements for quality reporting by specific providers (acute care hospitals, PPS- exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities (IPFs)) that are participating in Medicare. We also are establishing new administrative, data completeness, and extraordinary circumstance waivers or extension requests requirements, as well as a reconsideration process, for quality reporting by ambulatory surgical centers (ASCs) that are participating in Medicare. We are establishing requirements for the Hospital Value-Based Purchasing (VBP) Program and the Hospital Readmissions Reduction Program.
Pre-Existing Condition Insurance Plan Program
This document contains an amendment regarding program eligibility to the interim final regulation implementing the Pre- Existing Condition Plan program under provisions of the Patient Protection and Affordable Care Act. In light of a new process recently announced by the Department of Homeland Security, eligibility for the program is being amended so that the program does not inadvertently expand the scope of that process.
Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle.'' The topic to be discussed is best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal.
MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities.'' The topic to be discussed is setting strategic priorities and implementing an action plan for sustainable partnership toward improving regulatory science and the public health.
Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public meeting entitled ``Public MeetingStrengthening the National Medical Device Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance system in the United States.
Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and New Drug Application Supplements; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide (CPG) Sec. 420.300 Changes in Compendial Specifications and New Drug Application (NDA) Supplements. CPG Sec. 420.300 is included in FDA's Compliance Policy Guides Manual available on the Agency's Web site at https://www.fda.gov/ICECI/ ComplianceManuals/CompliancePolicyGuidanceManual/default.htm.
Notice of FY 2012 Refugee Social Services Formula Awards to States and Wilson/Fish Alternative Project Grantees
The Office of Refugee Resettlement, Administration for Children and Families (ACF), announces the allocation of Refugee Social Services formula awards to States and Wilson/Fish Alternative Project grantees. The purpose of the Social Services program is to provide employment, English language, orientation, and other resettlement services to refugees, Amerasians, asylees, Cuban and Haitian entrants, victims of trafficking, and Iraqis and Afghans with Special Immigrant Visas. The awards are determined by the number of the eligible populations residing in the State during the two-year period from October 1, 2009, to September 30, 2011. States with allocations under $100,000 through this calculation instead receive floor allocations ranging from $75,000 to $100,000 depending on the number of the eligible population in each State. The purpose of the floor allocations is to ensure that all participating States receive an award sufficient to maintain a program of resettlement services. The FY 2012 formula allocations for Social Services are available on ORR's Web site at: https://www.acf.hhs.gov/programs/orr/policy/ fy2012_formula_allocations_refugee_socialservices.htm.
Medical Countermeasures for a Burn Mass Casualty Incident
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Medical Countermeasures (MCM) for a Burn Mass Casualty Incident.'' The purpose of this public workshop is to describe medical countermeasure requirements for burn injuries of radiological, nuclear, or chemical origin in a scarce resources environment; identify gaps in the product landscape so as to articulate a consensus-based needs assessment; discuss testing approaches and regulatory pathways; and to educate workshop attendees on the concept of medical utilization and response integration. The overall goal is to engage stakeholders across the public and private sector in strategic dialogue related to development, evaluation, deployment, and monitoring of medical countermeasures to mitigate the adverse health consequences arising from public health emergencies, specifically those involving radiological, nuclear, or chemical threats. Date and Time: The public workshop will be held on September 27, 2012, from 8:30 a.m. to 5 p.m. and September 28, 2012, from 8:30 a.m. to 12 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA-employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact: Suzanne Schwartz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G439, 301-796-6970, Fax: 301-847-8507, email: Suzanne.Schwartz@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on September 21, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Cindy Garris, email: Cynthia.garris@fda.hhs.gov or phone: 301 796-5861 no later than September 21, 2012. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Suzanne Schwartz to register (see Contact). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Persons interested in viewing the webcast must register online by 5 p.m. September 13, 2012. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 21, 2012. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, visit https:// www.adobe.com/go/connectprooverview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Requests for Poster Presentations: This public workshop will include a poster session. During online registration you may indicate if you wish to present an abstract during the poster session. FDA has identified general topics in this document. FDA will do its best to accommodate requests for poster presentation and will select and notify participants by September 7, 2012. All abstract submissions for poster presentations must be emailed to Suzanne Schwartz (see Contact) no later than 5 p.m. on August 31, 2012. No commercial promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop to obtain information on medical countermeasures for a burn mass casualty incident. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is October 31, 2012. However, only comments received prior to August 31, 2012 will be incorporated into the workshop while comments received after that date will be reviewed by FDA after the conclusion of the workshop. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in section II of this document, please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at https://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list.)
Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop
60-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works-Best Practice, Promising Practice, and Local Effort (BPPPLE) Form; Request For Public Comment
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917- 0034, ``Indian Health Service (IHS) Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form.'' Type of Information Collection Request: Extension without revision of the currently approved information collection, 0917-0034, ``IHS Sharing What WorksBPPPLE Form,'' which was previously approved under the title ``Director's 3 Initiative Best Practice, Promising Practice, and Local Efforts Form.'' Although the name of the form has changed, the contents of the form remain the same. Forms: IHS Sharing What WorksBPPPLE Form (OMB Form No. 0917-0034). Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and to provide the product/service to IHS, Tribal, and Urban (I/T/U) programs, the Office of Preventive and Clinical Services' (OCPS) program divisions (i.e., Behavioral Health (BH), Health Promotion/Disease Prevention (HP/DP), Nursing, and Dental) have developed a centralized program database of Best/Promising Practices and Local Efforts (BPPPLE) and resources. The purpose of this collection is to develop a database of BPPPLE and resources to be published on the IHS.gov Web site which will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. All information submitted is on a voluntary basis; no legal requirement exists for collection of this information. The information collected will enable the Director's Three Initiative program to: (a) Identify evidence based approaches to prevention programs among the I/ T/Us when no system is currently in place, and (b) Allow the program managers to review BPPPLE occurring among the I/T/Us when considering program planning for their communities. Affected Public: Individuals. Type of Respondents: I/T/U programs' staff. The table below provides: Types of data collection instruments, Number of respondents, Responses per respondent, Average burden hour per response, and Total annual burden hour(s).
30-Day Proposed Information Collection: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions; Request for Public Comment
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. This proposed information collection project was previously published in the Federal Register (77 FR 115) on June 14, 2012 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions (OMB No. 0917-0028). Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0028, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions.'' Although there was a change on the form ``Addendum to Declaration for Federal Employment, Child care and Indian Child care Worker Positions'' (OMB No. 0917-0028), where the item number 15a was changed to 16 to reflect a change in the same item number on the ``Declaration for Federal Employment'' form (OPM OF 306; OMB No. 3206-0182), there are no program changes or adjustments in burden hours. Form Number: OMB No. 0917-0028. Forms: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions. Need and Use of Information Collection: This is a request for approval of the collection of information as required by Section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law (Pub. L.) 101-630, 104 Stat. 4544, and 25 United States Code (U.S.C.) Sections 3201-3211. The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. 25 U.S.C. 3207 requires regulations prescribing the minimum standards of character to ensure that none of the individuals appointed to positions involving regular contact with, or control over, Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution; crimes against persons; or offenses committed against children. In addition, 42 U.S.C. 13041 requires each agency of the Federal Government, and every facility operated by the Federal Government (or operated under contract with the Federal Government), that hires (or contracts for hire) individuals involved with the provision of child care services to children under the age of 18 to assure that all existing and newly hired employees undergo a criminal history background check. The background investigation is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal Government, or for a facility or program operated by (or through contract with) the Federal Government, in positions involved with the provision of child care services to children under the age of 18, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ``International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward.'' This workshop, the third in a series of specialized vaccine workshops, will review new methods and approaches for acellular pertussis (aP) vaccine safety testing that incorporate innovations in science and technology. These scientific innovations should improve test accuracy, precision, and efficiency while also reducing or replacing the use of animals in vaccine safety testing. The goal is to address the path toward global validation, acceptance, and implementation of scientifically valid alternative methods for aP vaccines. The workshop is open to the public at no charge with attendance limited only by the available space; however, advance registration is required (see DATES). NICEATM also invites submission of abstracts for scientific posters for display at the workshop (see SUPPLEMENTARY INFORMATION).
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food. This action is in response to a petition filed by Lallemand, Inc. (Lallemand).
Notice of the Award of a Single-Source Program Expansion Supplement Grant to Catholic Charities of Southern Nevada in Las Vegas, NV, a Wilson-Fish Project
The Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to Catholic Charities of Southern Nevada, Las Vegas, NV, in the amount of $437,650 under the Wilson-Fish Program. The supplemental award will allow the grantee to provide cash and medical assistance to arriving refugees and others who are also eligible for refugee benefits through the remainder of Federal Fiscal Year (FY) 2012. The expansion supplement award will enable the grantee to provide assistance to a higher number of clients than originally planned.
Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL
The Food and Drug Administration (FDA) has determined the regulatory review period for TORISEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Shane Mayack, Ph.D., Joslin Diabetes Center: Based on the report of an investigation conducted by the Joslin Diabetes Center (Joslin) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Shane Mayack, former postdoctoral fellow, Department of Developmental and Stem Cell Biology, Joslin, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants T32 DK07260-29 and P30 DK036836 and the 2008 NIH Director's New Innovator Award Program grant DP2 OD004345-01. ORI found that Respondent engaged in research misconduct involving two (2) published papers:
Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
This document corrects a technical error in the notice [Document Identifier: CMS-10003] entitled ``Notice of Denial of Medical Coverage (or Payment)'' that was published in the July 6, 2012 (77 FR 40064) Federal Register.
Privacy Act, Exempt Record System
The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.'' HHS/FDA proposes to exempt this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations.
Privacy Act, Exempt Record System
The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.'' HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
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