Department of Health and Human Services March 2010 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 369
Determination That HalfLytely and Bisacodyl Tablets Bowel Prep Kit (Containing 4 Bisacodyl Delayed Release Tablets, 5 Milligrams) Was Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that HALFLYTELY AND BISACODYL TABLETS BOWEL PREP KIT (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and 4 bisacodyl delayed release tablets, 5 milligrams (mg) (20-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and 4 bisacodyl delayed release tablets, 5 mg.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Regional Collaborative for the Pacific Basin (RCPB) Cooperative Agreement
HRSA will be providing supplemental funds to support activities for a regional Pacific Primary Care Organization to represent the six U.S.-affiliated Pacific Basin jurisdictions. The supplemental funds will be used to augment the grantee's current
National Institutes of Health Guidelines for Human Stem Cell Research
The National Institutes of Health (NIH) is extending the public comment period on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). Due to a technical problem, comments entered in the Web site between 11:59 p.m. EST on February 28, 2010, through 8 a.m. EST on March 2, 2010, were not received by the agency and should be re-entered in order to be considered.
Oral Dosage Form New Animal Drugs; Tetracycline Powder
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 Alpharma, Inc. The supplemental NADA provides for revised labeling for a 25 gram per pound concentration of tetracycline hydrochloride soluble powder used to make medicated drinking water for calves, swine, chickens, and turkeys for the treatment and control of various bacterial diseases.
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.
Task Force on Childhood Obesity: Request for Information
Across the country, childhood obesity has reached epidemic rates. On February 9, 2010, President Obama signed a Presidential Memo establishing a Task Force on Childhood Obesity that directs Federal agencies to create a comprehensive interagency national action plan to solve the challenge of childhood obesity within a generation. The Presidential Memo directs the Task Force to focus on four pillars: Ensuring access to healthy, affordable food; increasing physical activity in schools and communities; providing healthier food in schools; and empowering parents with information and tools to make good choices for themselves and their families. This notice announces a request for public comments to assist the Task Force in making recommendations on public and private sector actions that can be taken to solve the problem.
Notice of Availability of Final Policy Document
HRSA is publishing a Final Agency Guidance (``Policy Information Notice'' (PIN) 2010-01) to describe the documentation that will be considered by the Health Resources and Services Administration (HRSA) in confirming public agency status for organizations that self- identify as public agencies (also referred to in previous PINs as ``public entities'' or ``public applicants'') for Health Center Program grant funding authorized under section 330 of the Public Health Service Act, as amended, and/or for Federally Qualified Health Center Look- Alike designation. The PIN, ``Confirming Public Agency Status under the Health Center Program and FQHC Look-Alike Program,'' and the Agency's ``Response to Public Comments'' are available on the Internet at http:/ /bphc.hrsa.gov/policy/pin1001/and https://bphc.hrsa.gov/policy/pin1001/ PublcCommentsPIN2010-01.pdf, respectively.
Prescription Drug User Fee Act; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting on the Prescription Drug User Fee Act (PDUFA). The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on PDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes, and publish the comments on FDA's Web site. FDA invites public comment on the PDUFA program and suggestions regarding the features FDA should propose for the next PDUFA program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions in FDA's cosmetic labeling regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations requiring that the agency receive prior notice before food is imported or offered for import into the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Family Smoking Prevention and Tobacco Control Act
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 collection of information pertaining to the submission of smokeless tobacco rotational warning plans under the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act), as amended by the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
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