Department of Health and Human Services August 11, 2010 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Health and Human Services, in its role as the Chair of the Interagency Working Group on Youth Programs, is announcing a meeting to solicit input from the public that will inform the development of a strategic plan for federal youth policy.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for trivalent influenza vaccines. In addition, to ensure that influenza vaccine information materials are available at the beginning of the upcoming influenza vaccination season, the proposed materials included in this notice are also considered interim vaccine information materials covering influenza vaccines for use pending issuance of final influenza materials following completion of the formal NCVIA development process.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for measles, mumps rubella (MMR); varicella, and measles, mumps, rubella; and varicella (MMRV).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Centers for Medicare and Medicaid Services (CMS), both part of the U.S. Department of Health and Human Services. The purpose of the MOU is to promote collaboration and enhance knowledge of efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to further enhance information sharing efforts through more efficient and robust inter- agency activities; promote efficient utilization of tools and expertise for product analysis, validation, and risk identification; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.

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 information collection provisions in the guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables.''

This notice announces COLA's voluntary withdrawal from the specialty of Pathology. COLA is an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program.