Department of Health and Human Services March 2013 – Federal Register Recent Federal Regulation Documents
Results 301 - 347 of 347
Adrian Vela: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adrian Vela for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Vela was convicted of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Vela was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 3, 2012 (30 days after receipt of the notice), Mr. Vela had not responded. Mr. Vela's failure to respond constitutes a waiver of his right to a hearing concerning this action.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)” (VICH GL36(R)); Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI 159) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI),'' (VICH GL36(R)). 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 provide guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.
Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III) and to incorporate additional types of communication, all of which increase the efficiency of the review process. This draft guidance is not final nor is it in effect at this time.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing” (VICH GL23(R)); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GFI 116) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)). This draft revised guidance is a revision of a final guidance on the same topic for which a notice of availability was published in the Federal Register of January 4, 2002, and has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In this draft revised VICH guidance the recommendation for a second test to evaluate the potential of a chemical to produce chromosomal effects is being revised. The draft revised guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the the following three tests: An in vitro chromosomal aberrations test using metaphase analysis, which detects both clastogenicity and aneugenicity; an in vitro mammalian cell micronucleus test, which detects the activity of clastogenicity and aneugenicity; or a mouse lymphoma test, which, with modification, can detect both gene mutation and chromosomal damage. This draft revised VICH guidance document is intended to facilitate the mutual acceptance of safety data necessary for the establishment of acceptable daily intakes for veterinary drug residues in human food by the relevant regulatory authorities.
Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and for Information
In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders and other interested parties an opportunity to submit comments and information that will help the Agency as it forms its own recommendations, to be contained in the Agency's report to Congress, and as it implements the FSMA provisions relating to the tracking and tracing of food.
Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for powered patient transport devices commonly known as stairway chair lifts. These devices are used to assist in the transfer of a person with a mobility impairment caused by injury or other disease up and down flights of stairs. This order exempts stairway chair lifts, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for stairway chair lifts. All other devices classified under FDA's powered patient transport regulations, including attendant-operated portable stair-climbing chairs (which are different from wheelchairs) continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Current List of Laboratories and Instrumented Initial Testing Facilities 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 and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF 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 https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Pulse OximetersPremarket Notification Submissions [510(k)s].'' This guidance document pertains to non-invasive pulse oximeters intended for prescription use to measure arterial blood oxygen saturation (SpO2) and pulse rate. This document supersedes the General Guidance Document entitled ``Device: Non-Invasive Pulse Oximeter'' issued on September 7, 1992, and represents the Agency's current thinking in regards to information that should be included in a premarket submission for a non-invasive pulse oximeter.
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment Period
The Food and Drug Administration (FDA or ``we'') is reopening the comment period for the interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics'' that published in the Federal Register of July 14, 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of September 7, 2005 (70 FR 53063), we amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. Therefore, we are reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum.
Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate) injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, if all other legal and regulatory requirements are met.
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