Department of Health and Human Services October 16, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 39 of 39
National Institute of Environmental Health Sciences; Request for Nominations for Voting Members To Serve on the National Institutes of Health (NIH), National Institute of Environmental Health Sciences' (NIEHS) Interagency Breast Cancer and Environmental Research Coordinating Committee
The National Institute of Environmental Health Sciences of the National Institutes of Health is requesting nominations for members to serve on the Interagency Breast Cancer and Environmental Research Coordinating Committee. This Committee will coordinate information on existing activities related to breast cancer and environmental research and make recommendations to the National Institutes of Health and other Federal agencies on how to improve existing research programs.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.'' This guidance document describes a means by which wound dressing with Poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify wound dressing with pDADMAC additive into class II (special controls). This guidance document is being immediately implemented as the special control for wound dressing with pDADMAC additive, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Plastic Surgery Devices; Classification of Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive
The Food and Drug Administration (FDA) is classifying the wound dressing with pDADMAC additive into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive,'' which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
Announcement of the Fourth Dietary Guidelines Advisory Committee Meeting and Solicitation of Written Comments
The Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) provide notice of the fourth meeting of the Dietary Guidelines Advisory Committee, and (b) solicit written comments pertinent to the Dietary Guidelines for Americans.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
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 requirements for administrative detention and banned medical devices.
Request for Nominations for Voting Members on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2010.
National Mammography Quality Assurance Advisory Committee; Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the National Mammography Quality Assurance Advisory Committee scheduled for November 2, 2009. This meeting was announced in the Federal Register of October 1, 2009 (74 FR 50803). The postponement is due to guidance documents planned for discussion at the meeting are not yet available. A future meeting date will be announced in the Federal Register.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of tulathromycin injectable solution for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed.
New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sometribove zinc suspension from Monsanto Co. to Elanco Animal Health, A Division of Eli Lilly & Co.
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.
Submission for OMB Review; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 16, 2009, page 34580 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.
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.
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