Department of Health and Human Services May 9, 2007 – Federal Register Recent Federal Regulation Documents

Proposals to conduct research involving the deliberate transfer of a tetracycline resistance trait to Chlamydia Trachomatis have been submitted to the NIH Office of Biotechnology Activities (OBA). The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Chlamydia infections in humans. Under the NIH Guidelines, these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approval by the NIH Director as Major Actions. These proposals will be discussed at the June 19-21, 2007 meeting of NIH Recombinant DNA Advisory Committee.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM request the submission of data and information on the use of topical anesthetics and systemic analgesics for alleviating pain and distress in rabbits during eye irritation testing. They also request the submission of information about other procedures and strategies that may reduce or eliminate pain and distress associated with in vivo eye irritation methods.

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.

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.

This notice, in accordance with 35 U.S.C. Sec. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in PCT Application No. PCT/US01/04125, filed February 9, 2001, entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-PCT-02]; U.S. Patent No. 7,148,061, issued December 12, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-US-03]; U.S. Patent Application No. 11/637,272, filed December 12, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E- 095-2000/0-US-08]; PCT Application No. PCT/US06/24909, filed June 26, 2006, entitled ``A Potential Novel Therapeutic Protein Molecule of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptor Type 1'' [E-095-2000/4-PCT-01]; European Patent Application No. 01910476.9, filed February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-EP-06]; Australian Patent Application No. 2001238076, filed on February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-AU-04]; Australian Patent Application No. 2006203490, filed on August 11, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-AU-07]; and Canadian Patent Application No. 2399388, filed February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-CA-05] to Welson Pharmaceuticals, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for rheumatoid arthritis (RA) using Welson's proprietary platform.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for the opportunity for pubic comment on the proposed data collection projects, the Warren Grant Magnuson Clinical Center (CC), the 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. Proposed Collection: Title: Customer and Other Partners Satisfaction Surveys. Type of Information Collection Request: New request/waiver. Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; and (4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center's operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer's needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households; businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center's major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: Clinical Center patients, family members of Clinical Center patients, visitors to the Clinical Center, National Institutes of Health investigators, NIH intramural collaborators, private physicians or organizations who refer patients to the Clinical Center, volunteers, vendors and collaborating commercial enterprises, small businesses, regulators, and other organizations. The annual reporting burden is as follows:

The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to a Stakeholder Dialogue. Attendees will meet the NCCAM Acting Director and discuss the Center's activities and priorities. The Dialogue will take place on June 20, 2007 in Bethesda, Maryland. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. To date, NCCAM's efforts to rigorously study CAM, to train CAM researchers, to conduct outreach, and to facilitate integration have been guided by NCCAM's strategic plans located on the NCCAM Web site at https://nccam.nih.gov/about/plans/fiveyear/index.htm. Request for Participation: The public is invited to provide input into the NCCAM's priorities and activities at a Stakeholder Dialogue. This event will give NCCAM stakeholders an opportunity to voice their opinions regarding future directions for research, training, outreach, and integration in complementary and alternative medicine (CAM). The Dialogue will be held: June 20, 2007, 9 a.m. to 3 p.m., Natcher Conference Center, National Institutes of Health,Bethesda, Maryland 20892. NCCAM's acting director will provide an overview of NCCAM's history and current activities, followed by a discussion with attendees. Dialogue attendees are welcome to participate in one of three afternoon breakout sessions (research, training, and communications) wherein there will be an opportunity to interact with NCCAM senior staff and discuss how NCCAM and the CAM community can work together in the future. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. Those wishing to attend should register by June 15, 2007. To register, please visit https://nccam.nih.gov/dialogue. For Further Information: To request more information, visit the NCCAM Web site at https://nccam.nih.gov/dialogue, call 1-888-644-6226, or e-mail info@nccam.gov.

The Food and Drug Administration (FDA) is classifying gene expression profiling test systems for breast cancer prognosis into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of oxytetracycline hydrochloride soluble powder for skeletal marking of finfish fry and fingerlings by immersion.

This notice announces the 11th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

This notice announces the 16th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)