Department of Health and Human Services September 22, 2006 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an option to a co-exclusive commercialization license to practice the inventions embodied in any or all of (a) U.S. patents 5,468,468 (11/21/ 1995); 5,833,986 (11/10/1998); 5,863,739 (01/26/1999); 5,965,359 (10/ 12/1999); 6,228,600 (05/08/2001) and 6,660,488 (12/09/2003), (b) U.S. patent applications 07/308,282 (02/09/1989, now abandoned), 07/915,884 (7/20/1992, now abandoned), 08/439,095 (05/11/1995, pending), 10/ 700,249 (11/03/2003, pending) and (c) foreign applications corresponding to PCT Patent Application PCT/US90/00617 entitled ``Type Alpha Platelet Derived Growth Factor Receptor Gene'', published as WO 90/10013 (9/7/1990) to AstraZeneca Pharmaceuticals LP having a principal place of business in Boston, MA. The prospective option to a co-exclusive license will have a Licensed Territory which is worldwide. The prospective option to the co-exclusive license will have a Field of Use limited to the development of compositions and methods of utilizing antibody-based products that specifically bind the alpha platelet-derived growth factor receptor ([alpha] -PDGFR/CD140a/PDGFRA/PDGF2/PDGFR-[alpha]), for the treatment of cancer and diagnostics specifically useful therewith. Only a single option to a co-exclusive license will be granted. This notice modifies the notice previously published at FR 69(165): 52514-15 (August 26, 2004).

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 announces the third 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.)

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 information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements for firms that intend to export certain unapproved medical devices.

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the eleventh meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 2, 2006, and from 9 a.m. to 3 p.m. on November 3, 2006, at the Bethesda DoubleTree Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (71 FR 39686) published on July 13, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0002, ``Indian Health Service Contract Health Service Report.'' Type of Information Collection Request: Extension of a currently approved information collection, 0917-0002, ``Indian Health Service Contract Health Service Report.'' Form Number: IHS 843-1A. Need and Use of Information Collection: The purpose for the collection is to authorize contract health care providers to provide health care services to eligible IHS patients. The IHS form 843-1A ``Order for Health Services'' was developed specifically for this collection of information. Other than revising the title ``Purchase-Delivery Order for Health Services'' to read ``Order for Health Services'', acquisition terms on the front of the form, the contract clauses contained on the back of copy 3 of the form, the form has not been revised and there is no change in the substance or in the use of the form. A copy of the form is at Attachment 2. The majority of the information contained in this form is completed by IHS staff from existing IHS automated patient and vendor data files. Contract health care providers complete and sign the streamlined form and submit it, along with a completed standard Centers for Medicare & Medicaid Services (CMS) health claim form (CMS 1450 (UB 92) and CMS 1500), to the IHS for verification and payment. The CMS forms are used and accepted nation-wide by the health care industry and IHS is an approved user. The information collected is needed to administer and manage the contract health care services provided to eligible American Indian and Alaska Native patients. The form is used to: Authorize contract health care services for eligible patients; certify that the health care services requested and authorized have been performed by the contract provider(s); process payments for health care services performed by such providers; obtain program data; and, serve as a legal document for health and medical care authorized by the IHS and rendered by health care providers under contract with the IHS. The information collected is also used for: Planning for further care of the patient; for keeping an accurate record of the patient's health status and health services received and recommended; for planning future health care programs; for communicating among members of the health care team; for evaluating the health care rendered; for research and continuing education; and, for the provision of program health statistics. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides the estimated burden hours for this information collection:

This document corrects a technical error in the notice that appeared in the Federal Register on September 18, 2006 entitled ``Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible for Calendar Year 2007.'' Effective Date: January 1, 2007.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Allied Chemical Corp. Plant, Metropolis, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluate, subject to revision as warranted by the evaluation, is as follows: Facility: Allied Chemical Corp. Plant. Location: Metropolis, Illinois. Job Titles and/or Job Duties: All workers at Allied Chemical Corp. Plant who were monitored or should have been monitored while they were working in any of the following: Feed Materials Building, Sodium Removal, Uranium Recovery Building, Sampling Plant, Laboratory Building, Ore Storage Locations. Period of Employment: January 1, 1959 to December 31, 1976.

The Food and Drug Administration (FDA) is announcing a public meeting and vendor display to discuss the issues associated with the development, implementation, and use of a unique device identification (UDI) system and the use of various automatic identification technologies. We are inviting individuals, companies, organizations, and other stakeholders to attend this public meeting, which will focus on the development and implementation of a UDI system; the benefits and costs of a UDI system; the use of automatic identification technologies; and the development, maintenance, and use of a repository for UDI related information. We are also inviting vendors of automatic identification technologies to display their products for the educational benefits of FDA and other attendees.

This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment allows certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This final rule also requires that nursing facilities at least install battery-operated single station smoke alarms in resident rooms and common areas if they are not fully sprinklered or they do not have system-based smoke detectors in those areas. Finally, this final rule confirms as final the provisions of the March 25, 2005 interim final rule with changes and responds to public comments on that rule.