Medicare and Medicaid Programs; Application From the Center for Improvement in Healthcare Quality (CIHQ) for CMS-Approval of Its Hospital Accreditation Program
This proposed notice with comment period acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.'' This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. This draft guidance is not final nor is it in effect at this time.
Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2013.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN TRANSCATHETER HEART VALVE
The Food and Drug Administration (FDA) has determined the regulatory review period for SAPIEN TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), March 27, 2013
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Announcement of the Re-Approval of the Commission on Office Laboratory Accreditation (COLA) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of the Commission on Office Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that COLA meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant COLA deeming authority for a period of 6 years.
Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
This proposed rule would implement medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program under the Patient Protection and Affordable Care Act.
Nominations to the Advisory Committee on Blood and Tissue Safety and Availability
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The ACBTSA is a federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Extreme Weather Effects on Medical Device Safety and Quality
The Food and Drug Administration (FDA) is studying the potential effects of extreme weather and natural disasters on medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.
Office of Biotechnology Activities; Recombinant DNA Research: Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Concerns about the emergence of a pandemic influenza virus have spurred research with influenza viruses that have the potential to cause a pandemic, such as highly pathogenic avian influenza (HPAI) H5N1 viruses. In 2012, two published studies funded by the National Institutes of Health (NIH) examined genetic changes that would allow HPAI H5N1 viruses to transmit by respiratory droplets among ferrets, an animal model that is often used to predict transmission and pathogenicity of influenza viruses in humans. This research raised concerns regarding the potential for HPAI H5N1 viruses to evolve and lead to a global pandemic. If transmission of a genetically engineered HPAI H5N1 virus among ferrets by respiratory droplets indicates that HPAI H5N1 viruses could evolve to transmit efficiently among humans by respiratory droplets, the public health risk of such a virus would be greater than that of the HPAI H5N1 virus currently circulating in poultry and wild birds, which does not easily transmit among humans. The NIH Recombinant DNA Advisory Committee (RAC) was asked to review the biosafety requirements for recombinant research with HPAI H5N1 virus contained in the October 2011 NIH Guidelines and determine whether these conditions and practices are adequate to address research with HPAI H5N1 viruses that transmit among mammals by respiratory droplets, as demonstrated in an appropriate animal model or clinically in humans (referred throughout this document as mammalian-transmissible HPAI H5N1). On January 24, 2013, the RAC held a public meeting, together with influenza experts, as well as experts from the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), HHS, the Food and Drug Administration (FDA), the World Health Organization (WHO), and the U.S. Department of Agriculture (USDA). The RAC recommended additional enhancements for research on mammalian-transmissible HPAI H5N1 virus to supplement the biosafety requirements for HPAI H5N1 that are already delineated in the NIH Guidelines. These enhancements include changes to the facility and biosafety equipment and practices, including occupational health practices. Based on the recommendations of the RAC, the NIH Office of Biotechnology Activities (OBA) concluded that more specific guidance regarding recombinant research with mammalian- transmissible HPAI H5N1 virus is warranted. The resulting amendments to the NIH Guidelines are ``Minor Actions'' under Section IV-C-1-(b)-2 of the NIH Guidelines, and therefore, will be implemented immediately upon publication in the Federal Register. While a Minor Action only requires consultation with the RAC chair and one or more RAC members, as necessary, as noted above, these changes were developed after extensive consultation with the full RAC and other experts and were discussed at a public RAC meeting. Publication in the Federal Register will inform the scientific and biosafety communities, as well as solicit continued scientific input should revisions be needed in the future.
National Institute for Occupational Safety and Health Personal Protective Technology for Pesticide Handlers: Stakeholder Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Pesticide Handler Personal Protective Technology Stakeholder Meeting''. Stakeholder Meeting Time and Date:
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email email@example.com or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)[Extension]. Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act), ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B drug discount program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to develop audit guidelines and because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs (OPA) developed a dispute resolution process for manufacturers and covered entities as well as manufacturer guidelines for audit of covered entities. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows:
Meeting for Software Developers on the Technical Specifications for 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. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by PSOs and other entities are clinically and electronically comparable. More information on the Common Formats, including the technical specifications, can be obtained through AHRQ's PSO Web site: http://www.PSO.AHRQ.GOV/index.html. The purpose of this notice is to announce a meeting to discuss the Common Formats technical specifications. This meeting is designed as an interactive forum where PSOs and software developers can provide input on these technical specifications. AHRQ especially requests input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the formats electronically.
Patient Safety Organizations: Delisting for Cause for Independent Data Safety Monitoring, Inc.
AHRQ has delisted Independent Data Safety Monitoring, Inc. due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.
Announcement of Requirements and Registration for healthfinder.gov Mobile App Challenge; Correction
The Office of Disease Prevention and Health Promotion published a document in the Federal Register of December 6, 2012, announcing the requirements and criteria for the healthfinder.gov Mobile App Challenge. The document contained inaccurate wording in one subsection of the terms and conditions.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
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 (the PRA).
Flavored Milk; Petition to Amend the Standard of Identity for Milk and 17 Additional Dairy Products
The Food and Drug Administration (FDA) is announcing that the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have filed a petition requesting that the Agency amend the standard of identity for milk and 17 other dairy products to provide for the use of any safe and suitable sweetener as an optional ingredient. FDA is issuing this notice to request comments, data, and information about the issues presented in the petition.
Prospective Grant of Exclusive License: Development of MUC-1 Tumor Associated Antigens as Cancer Vaccines for Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastric Cancer, Kidney Cancer, Liver Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer and Pancreatic Cancer
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Bavarian Nordic Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA:
Tribal Consultation Meeting
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of two 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, 640(l)(4)].
Notice of Meeting of the ICD-9-CM Coordination and Maintenance Committee; Correction
This document corrects a notice that was published in the Federal Register on February 7, 2013 (78 FR 9055-9056). The title of the meeting announcement should read as follows: Notice of Meeting of the ICD-9-CM Coordination and Maintenance Committee. The first sentence of the notice should read as follows: National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff announces the following meeting: Name: ICD-9-CM Coordination and Maintenance Committee (C&M) meeting. Time and Date: 9:00 a.m.-5:00 p.m., March 5, 2013. Place: Centers for Medicare and Medicaid Services (CMS) Auditorium, 7500 Security Boulevard, Baltimore, Maryland 21244.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email firstname.lastname@example.org.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Period for Information Collection Provisions
The Food and Drug Administration (FDA or ``we'') is extending the comment period for the information collection provisions of the proposed rule on ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.