Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices
The Food and Drug Administration (FDA) is announcing its fifth public workshop on Computer Methods for Medical Devices entitled ``FDA/ NIH/NSF Workshop on Computer Models and Validation for Medical Devices.'' The purpose of the workshop is to present, discuss, and receive input on an FDA library of models and data relevant to medical devices (day 1) and present, discuss, and receive input on a strategy to assess the credibility of computer models used to evaluate medical devices (day 2).
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
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 reporting requirements for firms that intend to export certain unapproved medical devices.
Prospective Grant of A Start-Up Commercialization Exclusive License: The Development of Fenoterol Analogues for the Treatment of Brain and Hepatocellular Cancers
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Nova Therapeutics LLC of a start-up exclusive commercialization license to practice the inventions embodied in the following US Provisional Patent Application (and all domestic and foreign counterparts claiming priority to it): Serial No. 61/651,961, filed May 25, 2012, entitled, ``Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS Ref. E-139-2012/0-US-01]. The patent rights in this invention have been assigned to the Government of the United States of America. The prospective start-up exclusive commercialization license territory may be worldwide, and the field of use may be limited to:
Literature Review Approach “Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid”; Request for Information and Comments
The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) in conjunction with the NIH Office of Dietary Supplements (ODS) is planning a workshop to identify research needs based on consideration of the state of the science related to the safe use of high intakes of folic acid. The NTP and the ODS invite comments on an approach document, ``Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid,'' for review of the pertinent literature. The document is available on the NTP Folic Acid Request for Information (RFI) Web site (http:// ntp.niehs.nih.gov/go/38143). Information gathered through this request will be used in prioritizing topics for the state of the science workshop.
Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice
The Food and Drug Administration (FDA) is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference 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 (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents, and regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions
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.
National Institutes of Health Loan Repayment Programs
As a part of the Department of Health and Human Services (HHS)'s ongoing retrospective review initiative, the National Institutes of Health (NIH) is rescinding the existing regulations for two of its eight loan repayment programs and issuing in their place a new consolidated set of regulations governing all of the NIH Loan Repayment Programs (LRPs). There are currently eight programs, including three for researchers employed by the NIH (Intramural LRPs) and five for non-NIH scientists (Extramural LRPs). The Intramural LRPs include the Loan Repayment Program for Research with Respect to Acquired Immune Deficiency Syndrome (or AIDS Research LRP); Loan Repayment Program for General Research (or General Research LRP), which includes a program for the Accreditation Council for Graduate Medical Education (ACGME) Fellows; and Loan Repayment Program for Clinical Researchers from Disadvantaged Backgrounds (or Clinical Research LRP for Individuals from Disadvantaged Backgrounds). The Extramural LRPs include the Loan Repayment Program for Contraception and Infertility Research (or Contraception and Infertility Research LRP); Loan Repayment Program for Clinical Researchers from Disadvantaged Backgrounds (or Clinical Research LRP for Individuals from Disadvantaged Backgrounds); Loan Repayment Program for Clinical Research (or Clinical Research LRP); Loan Repayment Program for Pediatric Research (or Pediatric Research LRP); and Loan Repayment Program for Health Disparities Research (or Health Disparities Research LRP).
National Practitioner Data Bank
This final rule revises existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986 and section 1921 of the Social Security Act, governing the National Practitioner Data Bank, to incorporate statutory requirements under the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act). The Department of Health and Human Services (HHS) also is removing regulations which implemented the Healthcare Integrity and Protection Data Bank. Section 6403 of the Affordable Care Act, the statutory authority for this regulatory action, was designed to eliminate duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank (HIPDB) (established under section 1128E of the Social Security Act) and the National Practitioner Data Bank (NPDB). It requires the Secretary to establish a transition period to transfer all data in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank, and, once completed, to cease operations of the Healthcare Integrity and Protection Data Bank. Information previously collected and disclosed to eligible parties through the HIPDB will then be collected and disclosed to eligible parties through the NPDB. This regulatory action consolidates the collection and disclosure of information from both data banks into one part of the CFR.
Submission for OMB review; 30-day Comment Request: A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 2, 2013 (Volume 78, Page 105) and allowed 60-days for public comment. Two public comments were received and responded to. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), the National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting is postponed because key participants were unavailable due to unforeseen scheduling conflicts. In the meantime, FDA analysis of industry-submitted documents is ongoing. A new meeting date will be announced in the Federal Register.
Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food; Availability
The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 100.250 Food Facility RegistrationHuman and Animal Food (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on issues related to food facility registration under a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the requirement that certain food facilities register with FDA, the requirement that registered facilities biennially renew their registrations with FDA, and FDA's authority to suspend a food facility's registration.
Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose
The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; and transilluminator for breast evaluation. FDA is also announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. In addition, FDA is proposing to reclassify sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls) based on new information respecting the device. This action implements certain statutory requirements.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the April meeting, the Advisory Council will hear a presentation from an international partner on their efforts to address Alzheimer's disease. There will be a presentation on the priorities set during the May 2012 research summit and the milestones for achieving the 2025 goal. The federal partners will provide an update on progress implementing the National Plan to Address Alzheimer's Disease and discuss highlights of the 2013 Update to the National Plan.
Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4; Availability
The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4.'' These supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting devices'') that comply with the ISO 594-2 standard.
Agency Information Collection Activities: Proposed Collection: Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email firstname.lastname@example.org or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: Primary Care Faculty Development Initiative (OMB No. 0915-xxxx)[New]. Abstract: HRSA's Bureau of Health Professions, Division of Medicine and Dentistry, has contracted with Oregon Health and Science University (OHSU), contract HHSH250201200023C, to conduct the planning, execution, and evaluation of a nationally based, longitudinal Primary Care Faculty Development Initiative (PCFDI) demonstration project. OHSU has developed web-based survey instruments which will be used to evaluate the effectiveness of the planned curriculum and its implementation and to make recommendations to improve teaching and competency assessment in primary care educational activities. The two web-based surveys are Irvine's Leadership Behavior Survey and the Faculty Skill & Program Feasibility Survey. The objectives of the survey instruments are to: assess the feasibility and acceptability of an inter-disciplinary faculty development pilot program targeting primary care physicians; to measure the leadership skills of PCFDI faculty participants; and to assess the initial impact of faculty receiving training from an inter-disciplinary faculty development pilot program on their perception of skill development in the core content areas of leadership, change management, teamwork, panel or population management, competency assessment, and clinical microsystems. 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 Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:
New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Call for Collaborating Partners for National Women's Health Week
The Department of Health and Human Services (HHS), Office on Women's Health (OWH) invites public and private-sector health-related organizations to participate in National Women's Health Week (NWHW) as partners to help create awareness of women's health issues and educate women about improving their health and preventing disease.
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 to discuss implementation of the Patient Protection and Affordable Care Act. The meeting will be open to the public.
Medicaid Program; Increased Federal Medical Assistance Percentage Changes Under the Affordable Care Act of 2010
This final rule implements the provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) relating to the availability of increased Federal Medical Assistance Percentage (FMAP) rates for certain adult populations under states' Medicaid programs. This final rule implements and interprets the increased FMAP rates that will be applicable beginning January 1, 2014 and sets forth conditions for states to claim these increased FMAP rates.
Request For Public Comment: 60-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials And Privileges Files
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.