Department of Health and Human Services February 2006 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI), the Assistant Secretary for Health, and another Federal agency have taken final action in the following case: Amy Beth Goldring, University of California at Los Angeles: Based on an investigation conducted by the University of California at Los Angeles (UCLA) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, ORI found that Ms. Goldring, former graduate student, Department of Psychology, UCLA, engaged in scientific misconduct by falsifying or fabricating data and statistical results for up to nine pilot studies on the impact of vulnerability on decision-making from Fall 2000 to Winter 2002 as a basis for her doctoral thesis research. The falsified or fabricated data was included in a manuscript submitted to Psychological Science, in National Institutes of Mental Health (NIMH), National Institutes of Health (NIH), grant application 1 R01 MH65238-01A1, and in NIMH, NIH, pre-doctoral training grant T32 MH15750. Ms. Goldring has been debarred by another agency with joint jurisdiction for a period of three (3) years, beginning on May 13, 2005, and ending on May 13, 2008. On December 16, 2005, Ms. Goldring received a detailed explanation of ORI's proposed finding and was given thirty (30) days to contest the finding and the proposed administrative action. The thirty-day period has elapsed and ORI has not received a response. Accordingly, the following administrative action has been implemented for a period of three (3) years, beginning on January 18, 2006: (1) Ms. Goldring 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 a consultant.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Reports on the Status of Postmarketing Study CommitmentsImplementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.'' This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study status report for an approved human drug or licensed biological product; timeframes for FDA's review of postmarketing study commitments; and information about postmarketing study commitments that will be available to the public. The guidance is intended to assist applicants in meeting the requirements of section 130 of the Food and Drug Administration Modernization Act of 1997.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.'' This guidance document describes a means by which the implantable intra-aneurysm pressure measurement system 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 to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for implantable intra-aneurysm pressure measurement systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing that Danisco USA, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of polydextrose as a bulking agent, formulation aid, humectant and texturizer in all foods, except meat and poultry.

The National Institute for Occupational Safety and Health (NIOSH) has changed the selection of target organs used in dose reconstructions NIOSH produces under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) for energy employees with lymphoma cancers. This change responds to an evaluation by NIOSH of current scientific data on lymphoma, which revealed that the site of the radiation injury can differ from the site of the tumor or cancer origin documented in the medical files of a lymphoma cancer patient. The new process for selecting dose reconstruction target organs for energy employees with lymphoma cancers includes selecting the target organ that would have received the highest radiation dose from among relevant, possibly irradiated organs, as determined through the dose reconstruction process, when the identity of the target organ is in question. This change may result in the Department of Labor calculating higher probability of causation determinations for select lymphoma cases among previously decided and current EEOICPA cancer claims.

The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify bone sonometer devices from class III into class II, subject to special controls. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document entitled ``Class II Special Controls Guidance Document: Bone Sonometers'' that the agency proposes to use as a special control for these devices.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, Transmissible Spongiform Encephalopathies Advisory Committee, and the Vaccines and Related Biological Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will or may occur through December 31, 2006. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The Food and Drug Administration (FDA) is classifying the implantable intra-aneurysm pressure measurement system into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.