New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and 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 March 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug 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 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 paperwork associated with abbreviated new animal drug applications submitted to the Center for Veterinary Medicine, FDA.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Matthew Poore, Advanced Liquid Logic Inc.: Based on the report of an inquiry conducted by Advanced Liquid Logic Inc. (Liquid Logic), the Respondent's admission, and additional analysis conducted by ORI, ORI found that Mr. Matthew Poore, former Technician, Liquid Logic, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), contract HHSN272200900030C. ORI found that the Respondent engaged in research misconduct by falsifying data that were included in one (1) presentation and one (1) report to NIAID and in laboratory records at Liquid Logic. ORI finds that Respondent knowingly and intentionally falsified reverse transcription-polymerase chain reaction (RT-PCR) results by reporting the results from previous experiments as the actual results, when the experiments had not been performed. Specifically: In Liquid Logic laboratory documents, the Respondent falsified the RT-PCR results of human immunodeficiency virus (HIV) viral loads in whole blood patient samples by falsely changing previous results for two (2) samples from negative to positive and one (1) sample from positive to negative. The latter falsified sample result, changed from HIV positive to negative, was included in an April 1-June 30, 2012, quarterly report and a July 12, 2012, presentation to NIAID. In Liquid Logic laboratory documents, the Respondent falsified the RT-PCR whole blood lysis results of testing samples as 100 and 200 HIV viral copies per milliliter, when the experiments were not performed by the Respondent. These falsified results were included in an April 1-June 30, 2012, quarterly report to NIAID. In Liquid Logic laboratory documents, the Respondent falsified the graphs of RT-PCR results of the Escherichia coli bacteriophage MS2, an internal control, viral loads for three (3) clinical samples, when the results were actually from prior experiments of two (2) controls and one (1) unrelated clinical sample. The Respondent falsified the MS2 graphs in an effort to conceal that RT-PCR experiments of the clinical samples had not been performed. Mr. Poore has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on April 1, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate 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) To exclude himself voluntarily 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.
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 a meeting of the Advisory Committee on Minority Health (ACMH) will be held virtually. This virtual meeting will take place via webinar and audio video conferencing technology. This meeting will be open to the public. Preregistration is required for both virtual public participation and comment. Any individual who wishes to participate in the virtual public meeting and/or in the public comment session should preregister at the following email address: email@example.com.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3(b)(4). On April 19, 2013, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus. On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. Sec. 360bbb- 3(b)(1), subject to the terms of any authorization issued under that section. The Secretary also specified that this declaration is a declaration of an emergency with respect to in vitro diagnostics as defined under the Public Readiness and Emergency Preparedness (PREP) Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008.\1\
Announcement of Opportunity and Procedure To Submit Nominations for Nutrients of Interest for Dietary Reference Intake Reviews
The Dietary Reference Intake (DRI) Subcommittee, an entity within the federal Interagency Committee on Human Nutrition Research, has developed procedures jointly with its Canadian counterpart to allow interested parties to nominate nutrients for consideration for DRI review. This notice will serve to announce the opportunity to submit such information to the DRI Subcommittee as it considers updates for nutrients and food components that have previously been considered by Institute of Medicine DRI committees.