Department of Health and Human Services April 2007 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 311
Office of the National Coordinator for Health Information Technology, American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Extension of Timeline for Publication of Final Rule
This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with section 1871(a)(3)(B) of the Social Security Act, which allows us to extend the timeline for publication of the final rule.
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.
Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to May 3, 2007, the comment period for the notice of availability that appeared in the Federal Register of January 3, 2007 (72 FR 136). In the notice, FDA requested comments on the draft risk assessment, the proposed risk management plan, and the draft guidance for industry on animal cloning. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This guidance document describes a means by which herpes simplex virus type 1 and 2 (HSV 1 and 2) serological assays may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls).
Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
The Food and Drug Administration (FDA) is reclassifying herpes simplex virus (HSV) types 1 and/or 2 (HSV 1 and 2) serological assays from class III (premarket approval) to class II (special controls). FDA had earlier proposed this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled ``Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.''
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
National Toxicology Program (Ntp); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Second Bisphenol A Expert Panel Meeting and Availability of Interim Draft Expert Panel Report
CERHR announces the second meeting of the expert panel on bisphenol A on May 21-23, 2007, tentatively planned for the Washington, DC area. The interim draft expert panel report will be posted on the CERHR Web site (https://cerhr.niehs.nih.gov) and available in printed text from CERHR (see ``FOR FURTHER INFORMATION CONTACT'' below) by April 20. CERHR invites submission of written public comments on the interim draft expert panel report (see ``SUPPLEMENTARY INFORMATION'' below). The expert panel meeting is open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. CERHR also announces that the working groups for sections 3 and 4 of the expert panel report will meet April 5-6, 2007, in Durham, NC to continue discussions not completed at the March meeting.
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.
Announcement of Meeting To Discuss Soy Estrogens and Development
Beginning on Thursday, April 12, 2007 (9 a.m. to 4:30 p.m.) and continuing through Friday, April 13, 2007 (9 a.m.-12:30 p.m.), Dr. Walter Rogan of the National Institute of Environmental Health Sciences will sponsor a meeting with experts in pediatric endocrinology, psychology, epidemiology, and nutrition to discuss soy estrogens and infant development. The meeting will be held at the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina. During 2004-05, NIEHS conducted pilot studies to test innovative ethods for studying estrogenic isoflavones in soy formula and their potential ability to act as pharmacologic estrogens in infants by prolonging anatomical and biochemical markers in infants. The results of these studies are becoming available. While the investigators are at the early stage of planning what, if any, steps to take next, they have convened experts in pediatric endocrinology, psychology, epidemiology, nutrition, etc., to offer their individual opinions. This meeting is open to the public, but is limited by space. Registration is free but required. Please also note that the following security procedures must be followed when visiting the NIEHS: The purpose of a visit must be official (registered); The visit should be expected and approved by a ``host'' employee; Visitors must show an ID (Driver's license plus one of the following: company ID; government ID or university ID) at the entrance; Vehicles may be searched. Those interested in attending the meeting, or who have questions should contact: Kerry James by e-mail at james4@niehs.nih.gov or by telephone at 919-287-4339; or Janet Archer by e-mail at archer2@niehs.nih.gov or by phone at 919-287-4334.
Proposed Collection; Comment Request; Health Information National Trends Survey 2007 (HINTS 2007)
In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) request a review and approval of the information listed below. The proposed information collection was previously published in the Federal Register on October 26, 2006 on page 62597 and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. 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. Proposed Collection: Title: Health Information National Trends Survey 2007 (HINTS 2007). Type of Information Collection Request: NEW. Need and Use of Information Collection: Building on the first two rounds of HINTS data collection (HINTS 2003: OMB 0925-0507, Exp. Date: 8/31/03; and HINTS 2005: OMB 0925-0538, Exp. Date 11/30/2007), HINTS 2007 will continue to provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer, including cancer prevention, early detection, diagnosis, treatment, and prognosis. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained. HINTS is intended to be the foundation of NCI's effort to build on the opportunities presented by a national shift in communication context (for example, the increase in information available on the Internet and the use of email as a method of communication), and by so doing, improve the nation's ability to reduce the national cancer burden. Data will be used (1) to understand individuals sources of and access to cancer-related information; (2) to measure progress in improving cancer knowledge and communication to the general public; (3) to develop appropriate messages for the public about cancer prevention, detection, diagnosis, treatment, and survivorship; and (4) to identify research gaps and guide decisions about NCI's research efforts in health promotion and health communication. Frequency of Response: One time. Affected Public: Individuals. Type of Respondents: U.S. Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 11,670; Estimated Number of Responses per Respondent: 1.36; Average Burden Hours per Response: .24; and Estimated Total Annual Burden Hours Requested: 3,739. The annualized cost to respondents is estimated at: $59,824. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Determination of Regulatory Review Period for Purposes of Patent Extension; RANEXA
The Food and Drug Administration (FDA) has determined the regulatory review period for RANEXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE
The Food and Drug Administration (FDA) has determined the regulatory review period for KEPIVANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
The 10th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference
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