Department of Health and Human Services February 2012 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 287
Gastroenterology-Urology Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances
The Food and Drug Administration (FDA) is proposing to reclassify the sorbent hemoperfusion system, a preamendments class III device, into class II (special controls) for the treatment of poisoning and drug overdose, and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the treatment of hepatic coma and metabolic disturbances. FDA is identifying the proposed special controls that the Agency believes will reasonably ensure the safety and effectiveness of the device for the treatment of poisoning and drug overdose. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.
National Institute of Child Health and Human Development; New Proposed Collection; Comment Request Stress and Cortisol Measurement for the National Children's Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Funds for Leadership Training in Pediatric Dentistry's Current Grantees; One-Year Extension
The Health Resources and Services Administration (HRSA) will be issuing a non-competitive one-year extension with funds for the Leadership Training in Pediatric Dentistry awards to Columbia University, The Regents of the University of California and the University of Washington. Up to $196,506 per grantee will be awarded over a one-year extended project period. The Leadership Training in Pediatric Dentistry program supports a national focus on leadership training in pediatric dentistry through the support of: (1) The postdoctoral training of dentists in the primary care specialty of pediatric dentistry for leadership roles in education, research, public health, advocacy, and public service related to oral health programs for populations of mothers and children (infants through adolescents), particularly children with special health care needs; (2) the development and dissemination of curricula, teaching models, and other educational resources to enhance maternal and child health (MCH) oral health programs; and (3) the continuing education, consultation, and technical assistance in pediatric oral health which address the needs of the MCH community. This extension with funds will allow HRSA's Maternal and Child Health Bureau (MCHB) to align its leadership training initiatives in oral health with HRSA's other oral health training investments.
Animal Drugs, Feeds, and Related Products; N-Methyl-2-Pyrrolidone; Correction
The Food and Drug Administration (FDA) published a document in the Federal Register of November 25, 2011 (76 FR 72617), codifying a method of detection for residues of n-methyl-2-pyrrolidone in edible tissues of cattle. That document contained a universal resource locator (URL) linking to the Agency's Web site that did not reflect the most recent URL.
American Chemistry Council; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that the American Chemistry Council (ACC) has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles and spill- proof cups designed to help train babies to drink from cups because these uses have been abandoned. PC resins are formed by the condensation of 4,4'-isopropylenediphenol (i.e., Bisphenol A (BPA)), and carbonyl chloride or diphenyl carbonate.
Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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 information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the Agency.
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 Linde Ceramics Plant in Tonawanda, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 2, 2012, 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 Savannah River Site in Aiken, South Carolina, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 2, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Hooker Electrochemical Company in Niagara Falls, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On February 2, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Medicare Program: Notice of Six Membership Appointments to the Advisory Panel on Hospital Outpatient Payment
This notice announces six new membership appointments to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). The six appointments to the 19 member Panel will each serve a 4-year period. Five of the new members will have terms that begin on February 1, 2012 and continuing through January 31, 2016. The sixth member's term will begin on August 1, 2012 and continuing through July 31, 2016. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their weights. The Panel also addresses and makes recommendations regarding supervision of outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Medicare Program; Reporting and Returning of Overpayments
This proposed rule would require providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of the date which is 60 days after the date on which the overpayment was identified; or any corresponding cost report is due, if applicable.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), previously published a notice (76 FR 243, 19 Dec 2011, pp. 78660-78661) seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). OHRP would like to announce a four week extension of the SACHRP nomination period. As a result of this extension, the nomination period will now end at the close of business on March 16, 2012.
Design and Methodology for Postmarket Surveillance Studies Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act''. The purpose of the public workshop is to provide a forum for discussion among FDA, industry, governmental agencies, academia, clinicians and various stakeholders with experience in epidemiology, statistics, and biomedical research to advance the design and methodologies for medical device surveillance studies in the ``postmarket'' setting, i.e., after FDA premarket approval or clearance of the device and marketing of the device has begun.
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.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice
The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800-606-7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: https:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled).
Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.'' This draft guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This draft guidance gives an overview of FDA's approach to determining biosimilarity.
Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
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 collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.
Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.'' This draft guidance is intended to provide sponsors with an overview of analytical factors to consider when assessing biosimilarity between a proposed protein product and a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This draft guidance provides an overview of FDA's approach to quality considerations in determining biosimilarity.
Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications
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 concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the requirements for an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.
RIN 1545-BJ60
These regulations finalize, without change, interim final regulations authorizing the exemption of group health plans and group health insurance coverage sponsored by certain religious employers from having to cover certain preventive health services under provisions of the Patient Protection and Affordable Care Act.
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