Department of Health and Human Services November 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.'' This guidance document has been developed as a special control guidance document to support the classification of the low energy ultrasound wound cleaner into class II (special controls). The device is intended for the cleaning and maintenance debridement of wounds. This guidance document describes a means by which the low energy ultrasound wound cleaner 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 the low energy ultrasound wound cleaner into class II (special controls). The guidance document is immediately in effect as the special control for the low energy ultrasound wound cleaner, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

This final rule adopts standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). These standards will be the foundation standards or the first set of final uniform standards for an electronic prescription drug program under the MMA, and represent the first step in our incremental approach to adopting final foundation standards that are consistent with the MMA objectives of patient safety, quality of care, and efficiencies and cost savings in the delivery of care.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Oak Ridge Institute for Nuclear Studies, Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 28, 2003 (68 FR 9690). The document announced that FDA had determined the regulatory review period for ZOMETA. A Request for Revision of Regulatory Review Period was filed for the product on May 4, 2005. FDA reviewed its records and found that the effective date of the investigational new drug application (IND) was incorrect due to a clerical error. Therefore, FDA is revising the determination of the regulatory review period to reflect the correct effective date for the IND.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of October 24, 2005 (70 FR 61455). The document announced an approval by the Office of Management and Budget. The document was published with an incorrect expiration date for OMB control number 0910-0345. This document corrects that error.

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.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

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.

NICEATM announces availability of the report ``The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Expert Panel Evaluation of the draft Background Review Document Addendum for In Vitro Test Methods For Identifying Ocular Corrosives And Severe Irritants.'' NICEATM invites public comment on the expert panel report. Copies of the expert panel report may be obtained on the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov, or by contacting NICEATM at the address given below.

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, Division of Ivy Animal Health, Inc. The ANADA provides for use of a melengestrol acetate Type A medicated article with monensin and tylosin Type A medicated articles to make three-way combination Type C medicated feeds for heifers fed in confinement for slaughter.