Department of Health and Human Services March 17, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Advertisements
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements, including third party disclosure, contained in FDA's regulations on prescription drug advertisements.
National Center for Complementary and Alternative Medicine Announcement of Workshop on Control/Comparison Groups for Trials of Non-Pharmacologic Interventions
The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to participate at a Workshop on the choice of control and comparison groups for trials of non-pharmacological interventions (NPI). The purpose of this workshop is to review the strengths and weaknesses of the various control/comparison groups used in studies of NPI and the most appropriate use of these control/ comparison groups. This workshop will be divided into six sessions that will feature presentations and discussions focusing on the selection of a particular control/comparison group(s) for a given research question. The first session will provide case studies from the NPI literature,
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination That CERNEVIT-12 (Multivitamins for Infusion) Was Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that CERNEVIT-12, multivitamins for infusion (retinol palmitate corresponding to retinol (Vitamin A) 3500 international units (I.U.), cholecalciferol (Vitamin D3) 200 I.U., DL alpha-tocopherol 10.2 milligrams (mg) corresponding to alpha-tocopherol (Vitamin E) 11.2 I.U., ascorbic acid (Vitamin C) 125 mg, nicotinamide (Vitamin B3) 46 mg, dexpanthenol 16.15 mg corresponding to pantothenic acid (Vitamin B5) 17.25 mg, pyridoxine hydrochloride 5.5 mg corresponding to pyridoxine (Vitamin B6) 4.53 mg, riboflavin sodium phosphate 5.67 mg corresponding to riboflavin (Vitamin B2) 4.14 mg, cocarboxylase tetrahydrate 5.8 mg corresponding to thiamine (Vitamin B1) 3.51 mg, folic acid 414 micrograms (mcg), D-biotin 60 mcg, and cyanocobalamin (Vitamin B12) 5.5 mcg), (hereinafter CERNEVIT-12 (multivitamins for infusion)), was withdrawn from sale for reasons of safety or effectiveness. FDA therefore will not accept or approve abbreviated new drug applications (ANDAs) for CERNEVIT-12 (multivitamins for infusion).
Agency Information Collection Activities; Submission for Office and Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
