Department of Health and Human Services May 2009 – Federal Register Recent Federal Regulation Documents
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Public Meeting of the President's Council on Bioethics
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-seventh and final meeting. The full agenda will be posted on the Council's Web site at https:// www.bioethics.gov prior to the meeting. 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); Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008); The Changing Moral Focus of Newborn Screening: An Ethical Analysis by The President's Council on Bioethics (December 2008); and Controversies in the Determination of Death: A White Paper by The President's Council on Bioethics (December 2008). Reports are forthcoming on organ transplantation, health care reform, and the future of national bioethics commissions.
Beverages: Bottled Water
The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determine whether any of the coliform organisms are E. coli. FDA also is amending the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli will be considered adulterated, and source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from use in the production of bottled water. FDA is also amending its bottled water regulations to require that, before a bottler can use source water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or eliminate the cause of E. coli contamination of that source, and that the bottler must keep records of such actions. Existing regulatory provisions require bottled water manufacturers to keep records of new testing required by this rule. This final rule will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
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 provisions of the final rule, ``Beverages: Bottled Water,'' published elsewhere in this issue of the Federal Register, which requires both domestic and foreign bottled water manufacturers that sell bottled water in the United States to maintain records of Escherichia coli testing and corrective measures, in addition to existing recordkeeping requirements.
Recruitment of Sites for Assignment of Corps Personnel Obligated Under the National Health Service Corps Loan Repayment Program (ARRA and FY 2010)
Under the American Recovery and Reinvestment Act of 2009 (ARRA), additional funds are available to expand the National Health Service Corps (NHSC) through its programs to provide access to, and improve quality of, primary health care for millions of underserved Americans. The HRSA is therefore announcing an approximate 16-month funding cycle for new NHSC Loan Repayment applications and awards. During this 16-month cycle, the NHSC Loan Repayment Program will accept applications for loan repayment awards until all funds are expended. The policies described in this notice will be effective for all NHSC loan repayment awards made using ARRA funding from June 2009, to September 30, 2010, and all NHSC loan repayment awards made using fiscal year (FY) 2010 funding (if funding is appropriated) from October 1, 2009, to September 30, 2010. Provisions regarding assignment of NHSC Scholarship Program participants for the upcoming program year will be announced through a subsequent Notice.
Office of the National Coordinator for Health Information Technology; Health Information Technology Extension Program
This notice announces the draft description of the program for establishing regional centers to assist providers seeking to adopt and become meaningful users of health information technology, as required under Section 3012(c) of the Public Health Service Act, as added by the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (ARRA).
Notice of Public Comment on Tribal Consultation Sessions
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, Notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal governments operating Head Start (including Early Head Start) programs. The purpose of the Consultation Sessions is to discuss ways to better meet the needs of Indian, including Alaska Native, children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importer's Entry Notice
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.
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Luprostiol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for luprostiol injectable solution from Intervet, Inc., to Virbac AH, Inc.
Draft Guidance for Industry on Presenting Risk Information in Prescription Drug and Medical Device Promotion; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Presenting Risk Information in Prescription Drug and Medical Device Promotion.'' This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when evaluating prescription drug advertisements (ads), restricted device ads, and prescription drug and device promotional labeling for their compliance with the Federal Food, Drug, and Cosmetic Act (the act) and relevant regulations. The guidance gives examples to illustrate FDA's thinking on these factors and is intended to help regulated industry gain a better understanding of what they should consider as they develop the content and format of their promotional communications.
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