Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
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 reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive drugs and animal feeds containing Veterinary Feed Directive drugs.
Meeting of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a meeting. The meeting is open to the public.
Medicare and Medicaid Programs: Hospice Conditions of Participation
This final rule revises the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The final conditions address the comments that we received on the proposed rule published on May 27, 2005. This final rule focuses on the care delivered to patients and their families by hospices and the outcome of that care. The final requirements continue to reflect the unique interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration's efforts to achieve broad based improvements in the quality of health care and our efforts to improve the quality of care furnished through the Medicare and Medicaid programs.
Office of the Assistant Secretary for Preparedness and Response; HHS Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop 2008.
The Department of Health and Human Services (HHS) is pleased to announce the upcoming HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2008, to be held September 24-26, 2008, in Arlington, VA. This third annual event will provide an open forum for pharmaceutical and biotechnology industry representatives, state and local first responders, Executive Branch officials, public health advocates, academicians, Congressional staff, and other key stakeholders to discuss critical issues surrounding the development, acquisition, and distribution of medical countermeasures against chemical, biological, radiological, nuclear, and naturally emerging threats, and to share their visions for the future of U.S. public health emergency preparedness. Featured topics will include PHEMCE progress over the past year in medical countermeasure development and acquisitions under the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats and the HHS Pandemic Influenza Implementation Plan; Biomedical Advanced Research and Development Authority (BARDA) anticipated advanced development contracts and procurements under Project BioShield; medical countermeasure use at the point of care; Pandemic and All-Hazards Preparedness Act (PAHPA) implementation; and developing and sustaining a biodefense industry. This year's Workshop will also feature BARDA Industry Afternoons and evening poster sessions, designed to provide unique opportunities for biotechnology and pharmaceutical industry representatives to showcase cutting-edge biodefense medical countermeasure advances in the areas of vaccines, therapeutics, diagnostics, and platform technologies.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).
Submission for OMB Review; Comment Request; Inventory and Evaluation of Clinical Research Networks
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Resources (NCRR), 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 March 24, 2008, Vol. 73, No. 57, page 15530, 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 October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Inventory and Evaluation of Clinical Research Networks. Type of Information Collection Request: REVISION of OMB 0925-0550 Expiration: 07/31/08. Need and Use of Information Collection: Through the original data collection, the IECRN project identified and surveyed clinical research networks to obtain data for two purposes: (1) To create a web-based inventory of clinical research networks that can be accessed by the clinical research community and the general public and (2) to prepare a detailed description of existing network practices from a sample of identified networks. The current request is to continue collecting data for the first purpose only. The instrument known as the Core Survey will be used to collect information to confirm that the respondent is truly a clinical research network, plus basic characteristics about each identified clinical research network to be included in the web-based inventory. The information for the inventory database includes the network's name, address, contact information, funding sources, age, geographic coverage, size, composition, and populations and diseases of focus. Permission to post the network's data in the web-based public inventory will be requested, and only those networks that agree will have their information posted. Currently the inventory includes ``network profiles'' for approximately 270 clinical research networks. While this number is believed to represent most of the existing networks, some networks have not yet been identified, are unaware of the existence of the inventory, or are newly formed since the original data collection occurred. In addition, each network in the inventory is requested annually to update the information posted in its ``network profile'' to ensure that the inventory is complete and accurate. Frequency of Response: Once (Core Survey), Annually (Network Updates). Affected Public: Individuals; Type of Respondents: Health Professionals (Physicians and others involved in research networks).
Notice of Availability of Draft Guidances To Assist in Preparation for an Influenza Pandemic
The Department of Health and Human Services (HHS) is seeking public comment on three draft guidances: Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. The draft Guidances are now available on the HHS Web site http://aspe.hhs.gov/panflu/antiviral-n-masks.htm
Public Meeting of the President's Council on Bioethics
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-third meeting, at which it will discuss its projected White Paper on newborn screening and hear and discuss presentations on the ethics of health care reform. Subjects discussed at past Council meetings (although not on the agenda for the June 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, and lifespan extension. 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 on controversies in the determination of death and on organ donation, procurement, allocation, and transplantation are forthcoming.
Surgeon General's Conference on the Prevention of Preterm Birth
The Surgeon General's Office, in conjunction with the National Institutes of Health, is hosting a conference titled: Surgeon General's Conference on the Prevention of Preterm Birth. The conference is open to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recall 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 FDA's recall regulations and provides guidance to manufacturers on recall responsibilities.
Preparation for International Cooperation on Cosmetics Regulations Meetings in Washington, DC; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR Meetings in Washington, DC'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Washington, DC. The topics to be discussed are the topics for discussion at the forthcoming ICCR steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Washington, DC, the week of July 28, 2008, at which the action items from the first ICCR meeting are to be discussed.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
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 reporting requirements associated with extralabel drug use in animals.
Food Labeling Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on August 12, 2008, from 8 a.m. to 5 p.m., and on August 13, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253- 4970, or email: email@example.com. For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575- 4221, FAX: 479-575-2165, or email: firstname.lastname@example.org. Registration: You are encouraged to register by July 29, 2008. The University of Arkansas requires a $150 registration fee to cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop, beginning at 8 a.m. The cost of registration at the site is $200, payable to: ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the following form and submit along with a check or money order for $150, payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704.
Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 15, 2008 (73 FR 28119), announcing FDA's determination of the regulatory review period for TYZEKA. The document published with an incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Inspection Under the Inspection by Accredited Persons Program
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 eligibility criteria and the process to be followed by establishments when requesting FDA's approval to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the new inspections by the Accredited Persons Program.
Determination of Regulatory Review Period for Purposes of Patent Extension; VEREGEN
The Food and Drug Administration (FDA) has determined the regulatory review period for VEREGEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
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.
Prospective Grant of Exclusive License: Geldanamycin Derivative and Method of Treating Viral Infections
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent No. 6,890,917, issued May 10, 2005, entitled ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [E-050-2000/0-US- 15] and foreign equivalents. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the manufacture, use, distribution and sale of 17-DMAG, an analog of geldanamycin, as a therapeutic to inhibit the influenza virus, respiratory syncytial virus (RSV) and dengue virus.
Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Lloyd, Inc. The ANADA provides for the veterinary prescription use of butorphanol tartrate injectable solution in horses for the relief of pain.
Food Safety Research; Investigations Focused on Promoting the Safety of Produce
The Food and Drug Administration (FDA-Center for Food Safety and Applied Nutrition (CFSAN)) is announcing the availability of approximately $1.0 million in research funds for fiscal year (FY) 2008. It is anticipated that individual grants will receive a total of $250,000 to $500,000 to cover both direct and indirect costs. These funds will be used to support research efforts to advance the safe transportation and preparation of produce and to help reduce the incidence of foodborne illness that may be associated with fresh produce consumption. The award will provide 18 months of support. There will be no additional years of noncompetitive continuation support. A copy of the full text of this announcement will be posted in Grants.gov and on FDA's Center for Food Safety and Applied Nutrition Web site at http://www.cfsan.fda.gov/list.html. Key Dates: Receipt Date: Applications are due within 90 days after the publication of the funding opportunity in the Federal Register. I. Funding Opportunity Description
Guidance for Industry on Indexing Structured Product Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Indexing Structured Product Labeling.'' This guidance explains that the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drug and biologic products. This guidance also makes recommendations to industry on how to submit input regarding the indexing information in the SPL.