Department of Health and Human Services April 2008 – Federal Register Recent Federal Regulation Documents

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

The Food and Drug Administration (FDA) is announcing a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions (see section III of this document), and other pertinent information from interested parties. In addition, interested parties may provide views on which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antimicrobial- resistant bacteria, potentially qualify for available grants and contracts or other development incentives.

This rule finalizes the February 4, 2005 proposed rule entitled ``Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities.'' It establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement. This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.

The U.S. Department of Health and Human Services (HHS) announces the second in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2020, to be held online (via Webex software). This Committee meeting will be the equivalent of an in-person meeting of the Committee and will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.

This notice announces the 26th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 26th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 19th meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice is to inform the public that the Administration for Native Americans (ANA) intends to announce six (6) urgent grant awards. The urgent grant awards will fund projects that are designed to mitigate the impact of the devastation created by the Southern California Wildfires of October 2007. As a result of the devastating wildfires that destroyed approximately 1,500 homes and 500,000 acres of land, ANA is providing urgent financial assistance to five Tribes and one Tribal Association to address a variety of restoration activities that include reforestation and revegetation, debris removal, erosion control and restoration, emergency planning and preparedness. Contained herein is a description of the projects to be funded: Rincon Band of Luiseno Indians ($114,977 for 6 months) This project will assist in the restoration of 4,250 acres of tribal lands with the planting of 6,750 cottonwood, sycamore, and oak seedlings to provide erosion control. Santa Ysabel Band of Diegueno Indians ($155,230 for 6 months) This project will protect existing properties, protect the health and safety of community members, and make 300 acres of the reservation less vulnerable to wildfires. La Jolla Band of Luiseno Indians ($150,353 for 6 months ) The goal of the project is to protect tribal residents from injury, death or displacement and reduce the possibility of damage or losses to existing assets, particularly critical facilities/infrastructures owned by the tribe. The project will clear four drainage channels of debris that currently present a fire/flooding threat. Mesa Grande Band of Mission Indians ($72,772 for 6 months) This project will insure the safety of tribal members and protect tribal assets through the thinning and clearing of fire prone debris on 280 acres of tribal land. Pauma Band of Mission Indians ($29,949 for 3 months) This project will stabilize the banks of Pauma Creek to protect lives and property on the Pauma Reservation by placing cut rock along the Pauma Creek banks to prevent flooding. Southern California Tribal Chairman's Association ($126,123 for 6 months) This project will restore connectivity to the rural Tribes in Southern California by reestablishing access of high speed internet services with the reconstruction of one tower, repair of a second tower, and the repair and replacement of power sources and radio equipment for three towers. It will also develop, print, and disseminate disaster prevention brochures to all tribal members of the Southern California Tribes to provide information and inform them of the real-time access to information through the Internet.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System. This system of records is required to comply with the implementation directives of Public Law 109-129. HRSA published in the Federal Register of September 8, 2003, a document concerning notice of a new system of records, 09-15-0055, Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, 68 FR 52950. This document more fully explains the routine uses of records maintained in the system and amends the records' purpose and routine uses of records maintained in the system. Accordingly, the notice is published below in its entirety, as amended.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human somatic cell therapy. In addition, the guidance provides instructions to FDA reviewers about information to record and assess as part of the IND review. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications'' dated August 2003.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, and melengestrol acetate in three-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.

The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) Disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low income '' families.