Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents
Results 451 - 500 of 3,343
Possession, Use, and Transfer of Select Agents and Toxins
This document contains a technical correction to the list of select agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) published on October 16, 2008, in the Federal Register (73 FR 61363). This correction inserts ``Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight segments (Reconstructed 1918 Influenza virus)'' that was inadvertently omitted from the list of agents and toxins regulated by only HHS.
Notice of Allotment Percentages to States for Child Welfare Services State Grants
As required by section 423(c) of the Social Security Act (42 U.S.C. 623(c)), the Department is publishing the allotment percentage for each State under the Title IV-B Subpart 1, Child Welfare Services State Grants Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program.
Medicare Program; Listening Session on Hospital-Acquired Conditions in Inpatient Settings and Hospital Outpatient Healthcare-Associated Conditions in Outpatient Settings, December 18, 2008
This notice announces a listening session being conducted by the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention to solicit informal comments on hospital- acquired conditions (HACs) and hospital outpatient healthcare- associated conditions (HOP-HACs) in preparation for the fiscal year (FY) 2010 inpatient prospective payment systems (IPPS) and calendar year (CY) 2010 outpatient prospective payment system (OPPS) rulemaking processes. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and other interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. Verbal comments will be taken from telephone participants as time permits. This meeting is open to the public, but registration is required. Further information regarding this listening session will be posted on the HAC section of the CMS Web site at http:/ /www.cms.hhs.gov/HospitalAcqCond/01_Overview.asp and the OPPS section of the CMS Web site at https://www.cms.hhs.gov/hospitaloutpatientpps/.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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 waiver requirement procedures that are recommended by the agency for in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.
Memorandum of Understanding With the U.S. Army Medical Research Institute of Infectious Diseases
SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Army Research Institute of Infectious Diseases (USAMRIID). This MOU identifies the terms of collaboration between FDA and USAMRIID in the area of emergency preparedness. Specifically this MOU provides for the sharing of information and collaborative activities related to biological threat agents and diagnostics to detect such biological threat agents in order to assist both parties in more efficiently preparing for and responding to emergencies in which such diagnostic tests may be used.
Memorandum of Understanding With the National Heart, Lung, and Blood Institute, a Part of the National Institutes of Health
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Center for Biologics Evaluation and Research (CBER) and the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH). This MOU outlines the terms of collaboration between CBER and NHLBI in areas of mutual concern for protecting and improving the public health. Specifically this MOU provides for the implementation of a plan for promoting better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for discussion of scientific and clinical topics, questions, and problems that may arise. This MOU also provides the framework for sharing of information.
Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-10, Cis-12-Octadecadienoic Acids)
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a source of fatty acids in swine diets. This action is in response to a food additive petition filed by BASF Corp. (BASF), 100 Campus Dr., Florham Park, NJ.
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled ``Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products'' (73 FR 402, January 3, 2008) (interim final rule) and responds to comments submitted in response to the request for comments in the proposed rule of the same title (69 FR 21778, April 22, 2004) (proposed rule). This final rule affirms the interim final rule's requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act). The statement includes a toll- free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). This final rule also affirms the interim final rule's addition of new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (the BPCA) and the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Label Requirement for Food That Has Been Refused Admission Into the United States; Correction
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of Thursday, September 18, 2008 (73 FR 54106). The document issued a proposed rule that would require owners or consignees to label imported food that is refused entry into the United States. The preamble to the proposed rule inadvertently omitted a reference. This document corrects that error.
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.
Public Meeting of the President's Council on Bioethics
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-fifth meeting, at which it will discuss three topics: exercises of conscience in the practice of the health professions, the problem of medical futility, and the future of public bioethics and national bioethics commissions in the United States. Subjects discussed at past Council meetings (although not on the agenda for the November 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, standards for the determination of death, children and bioethics, and lifespan-extension among others. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), Taking Care: Ethical Caregiving in Our Aging Society (September 2005), and Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008). Reports are forthcoming on four topics: controversies in the determination of death; organ donation, procurement, allocation, and transplantation; newborn screening; and medical care and the common good.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories
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 a voluntary consumer survey of fishing and fish consumption habits in the Mississippi Delta.
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.
Opportunity for Hearing on a Proposal to Withdraw Approval of Prescription Polyethylene Glycol 3350 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is proposing to withdraw approval of the following abbreviated new drug applications (ANDAs) for drug products containing polyethylene glycol 3350 (PEG 3350) labeled for prescription only use: ANDA 76-652 held by Schwarz Pharma, Inc.; ANDA 77-736 held by Kali Laboratories, Inc.; ANDA 77-706 held by Nexgen Pharma Inc. (formerly known as Anabolic Laboratories, Inc.); ANDA 77-893 held by Coastal Pharmaceuticals, Inc.; and ANDA 77- 445 held by Teva Pharmaceutical Industries, Ltd. (collectively, the PEG 3350 ANDAs). The proposal is based on the switch of MiraLax from prescription only (``Rx only'') to over-the-counter (OTC) use. This switch was pursuant to the submission of a new drug application (NDA) for MiraLax (NDA 22-015), which was approved by the agency on October 6, 2006, establishing that PEG 3350 may be used safely and effectively without the supervision of a licensed healthcare professional. The Federal Food, Drug, and Cosmetic Act (the act) does not permit both Rx and OTC versions of the same drug product to be marketed at the same time. Under the act, a drug to which the prescription provisions of the act do not apply (i.e., an OTC drug) shall be deemed to be misbranded if at any time prior to dispensing the label of the product bears the ``Rx only'' symbol. Because the PEG 3350 generic drug products are labeled as Rx only, they are misbranded and may not be legally marketed. Thus, FDA is proposing to withdraw their approval.
Proposed Collection; Comment Request; Simulations for Drug Related Science Education
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 26, 2008, (Vol. 73 No. 124, page 36337) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module ArchieMD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforces or instills negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1,199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
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