Department of Health and Human Services April 4, 2007 – Federal Register Recent Federal Regulation Documents
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Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Virbac AH, Inc. The NADA provides for use of chewable tablets containing praziquantel and pyrantel pamoate in dogs and puppies for the treatment and control of various internal parasites.
New Animal Drugs for Use in Animal Feeds; Melengestrol and Lasalocid
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and lasalocid to make two- way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter.
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the cancellation of the 15th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup [formerly Biosurvellance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (the Task Force). The Task Force, a standing, independent panel of private-sector experts in prevention and primary care, is composed of members appointed to serve for four-year terms with an option for reappointment. New members are selected each year to replace (approximately) one fourth of the Task Force members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. Task Force members meet three times a year for two days in the Washington, DC area. Member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals can self nominate. Organizations and individuals may nominate one or more persons qualified for membership on the Task Force. Qualification Requirements: The mission of the Task Force is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the Task Force, an applicant or nominee MUST demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some Task Force members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Strongest consideration will be given to individuals who are recognized nationally or intentionally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair the scientific integrity of the work of the Task Force including financial, intellectual, or other conflicts.
Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is proposing to revise its labeling regulations applicable to foods (including dietary supplements) for which irradiation has been approved by FDA. FDA is proposing that only those irradiated foods in which the irradiation causes a material change in the food, or a material change in the consequences that may result from the use of the food, bear the radura logo and the term ``irradiated,'' or a derivative thereof, in conjunction with explicit language describing the change in the food or its conditions of use. For purposes of this rulemaking, we are using the term ``material change'' to refer to a change in the organoleptic, nutritional, or functional properties of a food, caused by irradiation, that the consumer could not identify at the point of purchase in the absence of appropriate labeling. FDA is also proposing to allow a firm to petition FDA for use of an alternate term to ``irradiation'' (other than ``pasteurized''). In addition, FDA is proposing to permit a firm to use the term ``pasteurized'' in lieu of ``irradiated,'' provided it notifies the agency that the irradiation process being used meets the criteria specified for use of the term ``pasteurized'' in the Federal Food, Drug, and Cosmetic Act (the act) and the agency does not object to the notification. This proposed action is in response to the Farm Security and Rural Investment Act of 2002 (FSRIA) and, if finalized, will provide consumers with more useful information than the current regulation.
Preparation for International Conference on Harmonisation Meetings in Brussels, Belgium; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Meetings in Brussels, Belgium'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Brussels, Belgium. The topics to be discussed are the topics for discussion at the forthcoming ICH steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working groups meetings in Brussels, Belgium May 5-10, 2007, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Friday April 6, 2007, from 3:30 p.m. to 5 p.m. Location: The meeting will be held at 5600 Fishers Lane, third floor, Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 3:20 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. Contact Person: Michelle Limoli, Office of the Commissioner (HFG- 1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0908, e-mail: michelle.limoli@fda.hhs.gov, FAX: 301-827- 0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material, and requests to make oral presentations, to the contact person by April 5, 2007. If you need special accommodations due to a disability, please contact Michelle Limoli as soon as possible.
Findings of Misconduct in Science
Notice is hereby given that on March 12, 2007 the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of the U.S. Public Health Service (PHS) in the following case: Rebecca Uzelmeier (formerly known as Rebecca Marcus), Michigan State University: Based on the report of an investigation by Michigan State University (MSU) and additional information obtained by the Office of Research Integrity (ORI) during its oversight review, ORI found that Rebecca Uzelmeier, former doctoral student, Department of Pharmacology and Toxicology, MSU, committed misconduct in science by intentionally and knowingly fabricating and falsifying data in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), granted R01 ES02520. ORI issued a charge letter enumerating the above findings of misconduct in science. However, on October 12, 2006, Ms. Uzelmeier filed a request for a hearing under 42 CFR part 93 to dispute these findings before the U.S. Department of Health and Human Services (HHS) Departmental Appeals Board (DAB). On October 19, 2006, ORI moved to dismiss Ms. Uzelmeier's hearing request because it failed to create a genuine dispute of either material fact or law, as required under 42 CFR 93.504. On March 5, 2007, the Administrative Law Judge (ALJ) with the DAB ruled in ORI's favor and dismissed Ms. Uzelmeier's hearing request pursuant to 42 CFR 93.504(a)(2). The ALJ found that Ms. Uzelmeier's hearing request raised defenses that either were immaterial to the charges of misconduct in science or that the ALJ had no authority to grant Ms. Uzelmeier's request for relief under Part 93. Specifically, Ms. Uzelmeier knowingly and intentionally; Fabricated and falsified data in her research notebook primarily by multiple instances of using data/results generated from one experiment to represent data/results purportedly obtained from one or more entirely different experiments; and Fabricated and falsified data in her thesis entitled ``Characterization of the Molecular Mechanism(s) Underlying the Interaction(s) between 2,3,7,8-tetrachlorodibenzo-p-Dioxin Mediated and Interferon Gamma Mediated Signal Transduction,'' including falsifying and fabricating autoradiographic films, computer image files scanned from those films, numerical data reduced from those computer files, documentation of those results in her black three-ring binder, and data in associated multiple figures and projection slides. Ms. Uzlmeier's research concerned the interaction between the environmental toxin, dioxin, and a cytokine, interferon, on cellular signaling in the immune system. The approach was to exploit dioxin, or ``TCDD'' (2,3,7,8-tetrachlorodibenzo-p-dioxin), as a probe that suppresses the immune system to delineate a role for the aryl hydrocarbon receptor protein (AhR), which is a cytosolic receptor that can be transported to the nucleus to also act as a nuclear transcription factor. The specific aim was to determine whether the mechanism of action of a naturally occurring regulatory factor, interferon-[gamma] (IFN-[gamma]), to antagonize the immunosuppressive actions of dioxin, was through reduced AhR signaling. Ms. Uzelmeier's actions caused the withdrawal of a manuscript that had been submitted for publication, the withdrawal of her mentor's PHS grant application, and her dismissal from graduate school. The following administrative actions have been implemented for a period of five (5) years, beginning on March 12, 2007: (1) Ms. Uzelmeier has been debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 2 CFR 180 and 376; and (2) Ms. Uzelmeier is prohibited 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 consultant.
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