Department of Health and Human Services February 21, 2013 – Federal Register Recent Federal Regulation Documents
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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: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
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 paperwork@hrsa.gov 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: https://www.PSO.AHRQ.GOV/. 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.
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