Department of Health and Human Services February 15, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
National Institutes of Health Proposed Collection; Proposed Reinstatement of Collection With Changes; Comment Request; Second National Survey To Evaluate the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Program
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director (OD), Office of Extramural Research (OER), Office of Extramural Programs (OEP), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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 If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing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 https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Draft Guidance for Industry on Developing Products for Weight Management; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Developing Products for Weight Management.'' FDA is interested in updating the September 1996 draft guidance entitled ``Guidance for the Clinical Evaluation of Weight-Control Drugs'' by incorporating the latest scientific and clinical advances in the drug development field of obesity, including recommendations on the development of products for weight management in pediatric patients and in patients with medication-induced weight gain, and recommendations on the development of combinations of weight-management products. This action is expected to provide clear and consistent advice to those in industry who are interested in developing weight-management products.
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of an additional dose of trenbolone acetate and estradiol implant used for increased rate of weight gain and improved feed efficiency in feedlot steers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Use E-Mail To Submit a Study Protocol
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 2, 2007 (72 FR 5057). The document announced that an opportunity for public comment on a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The notice published with an error in titles referring to an FDA form number in two places in the document. This document corrects those errors.
Sentinel Network To Promote Medical Product Safety; Public Meeting
The Food and Drug Administration (FDA) is extending to February 28, 2007, registration for the public meeting that will be held on March 7 and 8, 2007, regarding FDA's exploration and development of an integrated national network to link private sector and public sector postmarket safety efforts, creating a virtual, integrated, electronic ``Sentinel Network''. Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. Dates and Times: The public meeting will be held on March 7 and 8, 2007, from 8 a.m. to 5 p.m. Location: The public meeting will be held at the University System of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the 12th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Office of the National Coordinator for Health Information Technology, American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
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