Department of Health and Human Services August 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending its food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement ``Keep Refrigerated'' appears on the principal display panel (PDP) or information panel. This final rule will provide the industry greater flexibility in the placement of safe handling instructions on egg cartons, while continuing to provide consumers with this important information. This action is in response to numerous requests from the egg industry.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to establish a new system of records. The Stem Cell Therapeutic and Research Act of 2005 (the Act) authorizes the C.W. Bill Young Cell Transplantation Program (the Program) and provides for the collection, maintenance, and distribution of human blood stem cells for the treatment of patients and for research. The Program consists of four interrelated components each operated under a separate contract. The four components are: The Bone Marrow Coordinating Center; the Cord Blood Coordinating Center; the Office of Patient Advocacy/Single Point of Access; and the Stem Cell Therapeutic Outcomes Database. The contracts for operation of the Bone Marrow Coordinating Center, Cord Blood Coordinating Center, and Office of Patient Advocacy/Single Point of Access were awarded to the National Marrow Donor Program in September, 2006. A single contract for the Stem Cell Therapeutic Outcomes Database was awarded to the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin in September, 2006 as well. As identified by the Act, the Program is charged with: Operating a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients; operating a system for identifying, matching, and facilitating the distribution of donated umbilical cord blood units that are suitably matched to candidate patients; providing a means by which transplant physicians, other healthcare professionals, and patients can electronically search for and access all available adult marrow donors available through the Program; recruiting potential adult volunteer marrow donors; coordinating with other Federal programs to maintain and expand medical contingency response capabilities; carrying out informational and educational activities; providing patient advocacy services; providing case management services for potential donors; and collecting, analyzing, and publishing blood stem cell transplantation related data in a standardized electronic format. This system of records is required to comply with the implementation directives of the Act, Public Law 109-129. The records will be used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes.

The primary goal of this project is to assist Afghanistan in the development and strengthening of maternal and child health clinics/ hospital systems by creating equitable and high quality obstetrical and gynecological and infant care at RBH and developing an evidence-based and culturally appropriate Obstetrical/Gynecological residency program and continuing education program for practicing physicians. Projects requesting funding should aim to expand the capacity of Kabul Medical University to develop and implement curriculum reform in support of evidence-based medical knowledge and practice in maternal-child health at Kabul Medical University and to provide leadership and clinical expertise to strengthen the Obstetric and Gynecology Residency Program; residency training refers to a sustainable training of physicians and specialists in obstetrics and gynecology based on Western accreditation standards that have been modified for the Afghan situation. Announcement Type: Single EligibilityFY 2007 Initial Announcement. GSA Catalog of Federal Domestic Assistance: 93.017.

The primary goal of this project is to assist Afghanistan in the development and strengthening of maternal and child health clinics/ hospital systems by creating a solid, university-based, culturally- appropriate professional nursing educational program and building upon previous educational and training efforts. Funding is made available for the development of a basic baccalaureate program at Kabul Medical University and a registered nurse completion program at the Institute of Health Sciences (IHS) in Kabul, Afghanistan. The focus of both programs must be toward an emphasis on clinical training, to include the demonstration of direct patient care alongside Afghan health-care nurse providers. Announcement Type: Single EligibilityFY 2007 Initial Announcement. GSA Catalog of Federal Domestic Assistance: 93.017.

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 recordkeeping requirements for current good manufacturing practice (cGMP) regulations for Type A medicated articles.

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below 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) has determined that ORUDIS KT (ketoprofen) tablets, 12.5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ketoprofen tablets, 12.5 mg.