... [Federal Register: August 18, 2010 (Volume 75, Number 159 )] [Notices] [Page 51080-51081] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID: fr18au10-114]-DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-P-0386] Determination That DIASTAT (Diazepam Rectal Gel ), 5 Milligrams / Milliliter, 10 Milligrams / 2 Milliliter, 15 Milligrams / 3 Milliliter, and 20 Milligrams / 4 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice.-SUMMARY: The Food and Drug Administration (FDA) has determined that DIASTAT (diazepam rectal gel) (DIASTAT ), 5 milligrams (mg )/ milliliter (mL ), 10 mg / 2 mL, 15 mg / 3 mL, and 20 mg / 4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diazepam rectal gel, 5 mg / mL, 10 ...

... of 1972, as amended (16 U.S.C. 1361 et seq) and the regulations governing the taking and importing of marine mammals (50 CFR part 216). The amended permit allows an increase in the number of ringed, bearded, spotted, and ribbon seals that may be captured, from 50 per year to 100 per year, to allow for selection of animals of specific age, sex, and molt condition. The amendment also includes permission to (1) administer diazepam as needed to sedate seals acting aggressively during handling, (2) pull a whisker for stable isotope analyses of diet; and (3) use a dip net from a boat as an additional capture method. The amendment is valid for the duration of the permit, which expires on December 31, 2011. In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq ), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement. Dated: March 1, 2010 ...

... the ground that his `` continued registrations is inconsistent with the public interest ' Show Cause Order at 1 (citing 21 U.S.C. 824 (a )( 4) & 823 (f )). The Show Cause Order specifically alleged that on twenty-four different occasions between March 2007 and January 2009, Respondent had given prescriptions to law enforcement personnel for schedule II controlled substances including methadone, morphine, oxycodone, and hydromorphone, the schedule III controlled substance hydrocodone, and the schedule IV controlled substances alprazolam and diazepam. Id. at 1-2. The Order further alleged that Respondent's office did not have any exam rooms and medical equipment; that he did not take a medical history or require the officers to fill out any paperwork; did not conduct a physical examination; and that the officers would simply write their name, address and the drug they were seeking on a piece of paper which Respondent would take and then use to prepare a prescription. Id. at 2. The Order thus alleged that these prescriptions lacked a legitimate medical purpose and were issued in violation of 21 CFR ...