The Federal Register

New Animal Drugs; Change of Sponsor; Chloramphenicol Capsules

Tue, Dec 20 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for chloramphenicol capsules from Nylos Trading Co., Inc., to Pharmaceutical Ventures, Ltd.

Notice of Approval of Supplemental New Animal Drug Application; Tilmicosin

Tue, Dec 20 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The approved NADA provides for the veterinary prescription use of an injectable solution of tilmicosin phosphate for respiratory disease in cattle and sheep. This supplemental NADA adds user safety information to product labeling.

Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)

Tue, Dec 20 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients.

Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005.

Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850.

Contact: Eric Chen, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., 301443 8262, ext. 146, email: eac@cdrh.fda.gov, or Michael Berman (HFZ170), 12725 Twinbrook Pkwy., 3018274744, email: mrb@cdrh.fda.gov. If you nee

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Occupational Health and Safety

Tue, Dec 20 2005 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the following meeting:

Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Occupational Health and Safety Research, Program Announcement 04038 and Small Grants in
Occupational Safety and Health, Program Announcement 04021.

Time and Date: 1 p.m.3 p.m., January 13, 2006 (Closed).

Place: National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road, NE., Mailstop E74, Atlanta, GA 30333 Telephone Number (404) 4982582.

Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters To Be Considered: The meeting will include the review, discussion, and evaluation of applications rece

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Tue, Dec 20 2005 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Notification of Intent To Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction Under 21 U.S.C. 823(g)(2) (OMB No. 09300234)Revision

The Drug Addiction Treatment Act of 2000 (``DATA,'' Pub. L. 106 310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to permit practitioners (physicians) to seek and obtain waivers to prescribe certain approved narcotic treatment drugs for the treatment of opiate addiction. The legislation sets eligibility requirements and certification requirements as well as an interagency notification review process for physicians who seek waivers.

To implement these new provisio

Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

Tue, Dec 20 2005 11:00:00 GMT

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 fro