Department of Health and Human Services September 2009 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 292
Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket
The Food and Drug Administration (FDA) is announcing the opening of a public docket to receive information and comments regarding the current classification process related to electroconvulsive therapy devices (ECT). The current classification process for this device pertains to the ``Order for Certain Class III Devices; Submission of Safety and Effectiveness,'' published in the Federal Register of April 9, 2009 (74 FR 16214). Under the Order, FDA required manufacturers of certain Class III devices, including ECT, to submit a summary of, and citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). For each device subject to the Order, FDA is reviewing the submitted information to determine whether FDA should maintain the device as class III and require the submission of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP), or whether FDA should reclassify the device into class II or class I. FDA is now inviting interested persons to submit comments that relate to the safety and effectiveness of ECT.
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.
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Department of Health and Human Services' (HHS) receipt and review of the annual report submitted to the Secretary and Congress by the contracted consensus-based entity regarding performance measurement as mandated by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The statute requires HHS to publish not later than six months after receiving the annual report to Congress in the Federal Register together with any Secretarial comments.
Meeting of the National Vaccine Advisory Committee
A notice was published in the Federal Register on Wednesday, August 26, 2009, Vol. 74, No. 164, to announce that a meeting of the National Vaccine Advisory Committee will be held on September 15 and 16, 2009. The meeting is open to the public. The meeting proceedings also will be Webcast; the Webcast can be viewed at https:// videocast.nih.gov.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of human papillomaviruses.
Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
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 information collection contained in FDA regulations entitled ``Environmental Impact Considerations.''
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels
The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH).
Request for Notification from Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives on Medical Device Advisory Committee Panels and Request for Nonvoting Industry Representatives on Medical Device Advisory Committee Panels
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Pool of Nonvoting Industry Representatives for the Risk Communication Advisory Committee and Request for Nominations for Nonvoting Industry Representatives for the Risk Communication Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a pool of nonvoting industry representative candidates available to serve as temporary nonvoting members on its Risk Communication Advisory Committee (the Committee) for the Office of the Commissioner notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations for the pool will be accepted effective with this notice.
Privacy Act of 1974; Report of an Altered System of Records Medical Staff Credentials and Privileges Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes several administrative revisions which includes the deletion of the Social Security Numbers (SSNs) language to comply with the Office of Management and Budget (OMB) Memorandum (M)07- 16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eliminate the unnecessary collection and use of SSNs; and the inclusion of a new routine use to comply with OMB (M)07-16 and the HHS Memorandum dated September 19, 2007 to incorporate Notification of Breach Routine Use language; and the update of the Appendix 1 of the SOR.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 022
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 022'' (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
2009 Parenteral Drug Association and Food and Drug Administration Joint Regulatory Conference
The Food and Drug Administration (FDA) in co-sponsorship with the Parenteral Drug Association (PDA), is announcing a conference entitled ``Securing the Future of Medical Product Quality: A 2020 Vision.'' The workshop helps to achieve objectives set forth in the FDA Modernization Act of 1997, which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Customer Satisfaction Survey
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60-day advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
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.
Proposed Collection; Comment Request; NCCAM Customer Service Data Collection
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), will submit to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. A notice of this proposed information collection was previously published in the Federal Register on June 26, 2009 (Volume 74, Number 122, page 30577). To date, no public comments have been received. The purpose of this notice is to announce a final 30 days for public comment. NIH 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BANZEL
The Food and Drug Administration (FDA) has determined the regulatory review period for BANZEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
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