Department of Health and Human Services October 2011 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 305
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance is not final nor is it in effect at this time.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices
The Food and Drug Administration (FDA) is proposing to reclassify the external pacemaker pulse generator preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
Foreign Quarantine; Etiological Agents, Hosts, and Vectors
The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to revise the regulations that cover the importation of etiological agents and the hosts and vectors of human disease. The changes are proposed to improve CDC's ability to prevent the introduction, transmission, or spread of communicable diseases into the United States.
Interagency Task Force on Antimicrobial Resistance (ITFAR): An Update on A Public Health Action Plan to Combat Antimicrobial Resistance
The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH) announce an open meeting concerning antimicrobial resistance. The purpose of the meeting is to present the annual report on progress by Federal agencies in accomplishing activities outlined in A Public Health Action Plan to Combat Antimicrobial Resistance (Action Plan) and solicit comments from the public regarding ITFAR activities including the Annual Progress Report and the Action Plan. The meeting will take place at the Hubert H. Humphrey Building in Washington, DC on Tuesday, November 15, 2011 from 1 p.m.-3:30 p.m. The agenda will consist of welcome and introductory comments, a review of the Action Plan status and plans to update it; and reports of the progress toward implementing the Action Plan in each of the four focus areas: Surveillance, Prevention and Control, Research, and Product Development. The agenda is subject to change without notice. The meeting will then be open for comments from the general public. Persons wishing to participate, including those who wish to make an oral presentation, must register in advance and provide a copy of their presentation by noon Tuesday, November 8, 2011.
Agency Information Collection Activities; Proposed Collection; Comment Request; the Evaluation of the Aging and Disability Resource Center Program
The Administration on Aging (AoA) 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 Evaluation of the Aging and Disability Resource Center Program.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Nicola Solomon, Ph.D., University of Michigan Medical School: Based on an investigation conducted by the University of Michigan Medical School (UMMS) and a preliminary analysis conducted by ORI, ORI found that Dr. Nicola Solomon, former postdoctoral scholar, Department of Human Genetics, UMMS, engaged in research misconduct in research supported by the National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grants R37 HD030428 and R01 HD034283. Specifically, the Respondent did not perform DNA sequencing on 202 cDNA clones of homeobox genes to confirm their identity and integrity. Through multiple revision of the manuscript, the Respondent did not discuss this with the corresponding author or question and correct the corresponding author's addition of text indicating that the clones had been fully sequenced and were full length or longer (as indicated in Table 3) when compared to NCBI Mus musculus Unigene. This text supported the use of the Cap-Trapper technique to produce full length clones for the discovery of new genes without polymerase chain reaction (PCR). Both the Respondent and the U.S. Public Health Service (PHS) are desirous of concluding this matter without further expenditure of time and other resources and have entered into a Voluntary Settlement Agreement to resolve this matter. This settlement is not an admission of liability on the part of the Respondent. Respondent and ORI agreed to settle this matter as follows: (1) Respondent agreed that for a period of two (2) years beginning on September 16, 2011, prior to the submission of an application for PHS support for a research project on which her participation is proposed in a research capacity, and prior to her participation in this capacity on PHS-supported research, Respondent shall ensure that a plan for supervising her duties is submitted to ORI for approval; the supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she shall not participate as a researcher in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; and (2) Respondent agreed to exclude herself from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant, for a period of two (2) years, beginning on September 16, 2011.
Meeting of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting via teleconference. The meeting is open to the public.
Approaches To Reducing Sodium Consumption; Public Meeting
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Food Safety and Inspection Service (FSIS), the Agricultural Research Service (ARS) and the Center for Nutrition Policy and Promotion (CNPP) are announcing a public meeting entitled ``Approaches to Reducing Sodium Consumption.'' FDA and FSIS recently published a Federal Register notice that announced the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction. The purpose of the public meeting is to provide interested persons an opportunity to discuss the topics raised in the earlier notice.
Prospective Grant of Exclusive License: Secreted Frizzled Related Protein-1 (sFRP-1) and derivatives thereof and their Use In Therapeutic Applications
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 patents and patent applications belonging to the patent families having HHS Reference Numbers E-160-1997/0,/1,/2 and/3; E-014-2000/0; and E- 060-2000/0, and/1. Specific details regarding the individual patents or patent applications which belong to these patent families are set forth in the table below:
Prospective Grant of Exclusive License: The Development of Human Anti-Mesothelin Monoclonal Antibodies for the Treatment of Human Cancers
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 U.S. Patent Application 61/040,005 entitled ``Human Monoclonal Antibodies Specific for Mesothelin'' [HHS Ref. E-079-2008/0-US-01], PCT Application PCT/US2009/038228 entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-PCT-02], Australian patent application AU 2009228361 entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-AU-03], Canadian patent application CA 2718321 entitled ``Human Anti-Mesothelin Monoclonal Antibodies'' [HHS Ref. E-079-2008/0-CA-04], European patent application EP 09726082.2 entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-EP-05], U.S. patent application 12/934,060 entitled ``Human Anti-Mesothelin Monoclonal Antibodies '' [HHS Ref. E- 079-2008/0-US-06], and all related continuing and foreign patents/ patent applications for the technology family, to Sanomab, Ltd. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:
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; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
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