Department of Health and Human Services February 2005 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 326
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.
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.
Notice of Issuance of Final Policy Directive
The Administration for Native Americans (ANA) herein describes its issuance of final interpretive rules, general statements of policy and rules of agency procedure or practice relating to the Social and Economic Development Strategies (SEDS), Language Preservation and Maintenance (hereinafter referred to as Native Language), and Environmental Regulatory Enhancement (hereinafter referred to as Environmental) programs.
Reporting of Adverse Events to Institutional Review Boards; Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing to consider the process by which institutional review boards (IRBs) obtain and review information on adverse events that occur during the conduct of clinical investigations. FDA is increasingly aware of concerns within the IRB community that the process is burdensome, inefficient, and not as effective as it should be in providing IRBs the information they need to ensure that the rights and welfare of human subjects are protected during the course of a clinical study. The purpose of the hearing is to solicit information and views from interested persons on issues and concerns regarding the submission of adverse events to and their review by IRBs. FDA is seeking general information about the nature of the problem and possible solutions, responses to specific questions (see section III of this document), and any other pertinent information stakeholders would like to share. Date and Time: The public hearing will be held on March 21, 2005, from 9 a.m. to 5 p.m. Submit written or electronic notices of participation by 4:30 p.m. on March 4, 2005. Submit written and electronic comments by April 21, 2005. Location: The public hearing will be held at the Advisors and Consultants Staff Conference Room, 5630 Fishers Lane, Rockville, MD 20857. Addresses: Written or electronic notices of participation should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, e-mail: FDADockets@oc.fda.gov; or on the Internet at https:// www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdoc ket.cfm. Written or electronic comments should be submitted to https:// www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm or to the Division of Dockets Management (see Addresses above). Contacts: Nancy L. Stanisic, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration, 5600 Fishers Lane, rm. 9-64, Rockville, MD 20857, 301-827-1660, FAX: 301-443-9718, e-mail: stanisicn@cder.fda.gov. For Registration and/or to participate in the meeting: Because of limited seating, we recommend that persons interested in attending the meeting register at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Registration will be accepted on a first- come, first-served basis. The procedures governing the hearing are found in part 15 (21 CFR part 15). If you wish to make an oral presentation during the open public comment period of the hearing, you must state your intention on your registration form (see Addresses). To participate, submit your name, title, business affiliation, address, telephone, fax number, and e-mail address. You should also submit a written statement at the time of registration for each discussion question you wish to address, the names and addresses of all individuals that plan to participate, and the approximate time requested to make your presentation. Individuals who have registered to make an oral presentation will be notified of the scheduled time for their presentation prior to the hearing. Depending on the number of presentations, FDA may need to limit the time allotted for each presentation. Presentations will be limited to the questions and subject matter identified in section III of this document. Presenters should submit two copies of each presentation given. All participants are encouraged to attend the entire day. If you need special accommodations due to a disability, please inform the registration contact person when you register.
University of Arkansas/Food and Drug Administration Food Labeling; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Small Business Representative Program (SWR SBR), in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled ``UA/FDA 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 April 5, 2005, from 8 a.m. to 5 p.m., and on April 6, 2005, from 8 a.m. to 3 p.m. Location: The public workshop will be held at the Continuing Education Center in Fayetteville, AR, located downtown (2 East Center St.). 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 e-mail: seideman@uark.edu. For information on accommodation options, contact Steven C. Seideman (see Contact). Registration: Registration by March 21, 2005, is encouraged. The University of Arkansas has a $75 registration fee to cover the cost of facilities, materials, speakers, 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 $80 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 form below and submit along with a check or money order for $75 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. Name: Affiliation: Mailing Address: City: State: Zip Code: Phone: ( ) Fax: ( ) E-mail: ( ) Special Accommodations Required: Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
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 relating to FDA's electronic records and electronic signatures.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
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 firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (VICH GL-37); Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (160) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing'' (VICH GL- 37). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to establish recommendations for internationally harmonized repeat-dose chronic toxicity testing.
Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Notice of Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss our progress on development of a comprehensive, risk-based Animal Feed Safety System (AFSS) describing how animal feeds (individual ingredients and mixed feeds) should be manufactured, distributed, and used to minimize risks to humans and animals. We are seeking comments and assistance in our consideration of this safety program to effectively minimize the hazards to public health posed by animal feed products. Date and Time: The public meting will be held on Tuesday, April 5, 2005, from 8 a.m. to 5 p.m., and Wednesday, April 6, 2005, from 8 a.m. to 12:15 p.m. You may submit written or electronic comments at any time, but they would be most helpful if received on or before March 4, 2005. Location: The public meeting will be held at The Crowne Plaza, 655 North 108th Ave., Omaha, NE 68154, 402-496-0850.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
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 procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to FDA upon which it has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.
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