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

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.

The Food and Drug Administration (FDA) has determined the regulatory review period for MACUGEN 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.

The Food and Drug Administration (FDA) has determined the regulatory review period for FUZEON 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.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Public Availability of Labeling Changes in `Changes Being Effected' Supplements.'' The guidance announces to holders of a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), who intend to submit a ``Changes Being Effected'' supplement (CBE supplement) to make a postapproval labeling change, that FDA will make labeling revisions identified in a CBE supplement publicly available upon receipt of the supplement by FDA. The guidance does not have any bearing on supplements that relate to chemistry, manufacturing, and controls changes, nor does it expand the circumstances in which an ANDA holder may effect labeling changes via a CBE supplement.

The Food and Drug Administration (FDA) has determined the regulatory review period for CYDECTIN 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 animal drug product.

HRSA is requesting comments on the future direction and strategy regarding investments in health information technology (HIT) for section 330 grantees and other HRSA safety-net providers through its Office of Health Information Technology (OHIT). OHIT will evaluate all comments received during the public comment period to inform OHIT's policy direction.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2007. This premium is to be paid by enrollees age 65 and over who are not otherwise eligible (hereafter known as the ``uninsured aged'') and for certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2007 for these individuals will be $410. The reduced premium for certain other individuals as described in this notice will be $226. Section 1818(d) of the Social Security Act specifies the method to be used to determine these amounts.

The objective of this project is to mitigate any potential global shortage of influenza vaccines and the manufacturing of this vaccine in the event of an influenza pandemic. The Office of Public Health Emergency Preparedness (OPHEP) requires the World Health Organization (WHO) to perform activities related to pandemic influenza preparedness and planning, particularly in the international development of H5N1 human vaccines (and other pandemic influenza vaccine candidates) and influenza vaccine manufacturing infrastructure building in countries where resources for vaccine acquisition and manufacturing may be limited. The specific countries in which the WHO Secretariat will carry out these activities are Argentina, Brazil, India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. Activities include pre-clinical safety and immunogenicity testing, toxicology testing, clinical vaccine lot manufacturing, scale-up and process development, analytical lot release assay development and validation, and clinical immunogencity assay development and validation.