Department of Health and Human Services February 1, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of tulathromycin injectable solution for the treatment of infectious bovine keratoconjunctivitis and the addition of a pathogen to the indication for use for treatment of swine respiratory disease.
New Animal Drugs For Use in Animal Feed; Zilpaterol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of zilpaterol, monensin, and tylosin in three-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment
The Food and Drug Administration (FDA) is amending the regulation that establishes conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective (GRASE) and not misbranded. This amendment revises labeling requirements for OTC skin protectant drug products formulated and marketed as lip protectants.
Request for Notification from Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Blood Products Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Blood Products Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee, Center for Biologics Evaluation and Research (CBER), notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy on September 30, 2008, effective with this notice.
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:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
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