Department of Health and Human Services March 4, 2013 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-04900
Type: Notice
Date: 2013-03-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator
Document Number: 2013-04899
Type: Rule
Date: 2013-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-04897
Type: Rule
Date: 2013-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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).
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-04896
Type: Notice
Date: 2013-03-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2013-04874
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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 http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-04870
Type: Notice
Date: 2013-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2013-04869
Type: Rule
Date: 2013-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-04853
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-04852
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-04851
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-04850
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-04849
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-04847
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-04846
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-04845
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, National Institutes of Health
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
Document Number: 2013-04827
Type: Notice
Date: 2013-03-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: 2013-04826
Type: Notice
Date: 2013-03-04
Agency: Department of Health and Human Services, Administration for Children and Families