Proposed vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), Varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines--CDC. Notice with comment period

Under the National Childhood Vaccine Injury Act (42 U.S.C. section 300aa-26), CDC must develop vaccine information materials that 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 hepatitis B, Haemophilus influenzae type b, and Varicella vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines.     

Interim polio vaccine information materials. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

The Centers for Disease Control and Prevention has modified its recommendation for use of the two polio vaccines to discourage use of oral poliovirus vaccine (OPV) for the first two doses administered, except in limited circumstances. This revised recommendation necessitates a revision of the vaccine information statement entitled, "Polio Vaccines: What You Need to Know" (dated February 6, 1997), which was developed by the CDC as required by the National Childhood Vaccine Injury Act of 1986 (NCVIA). To ensure that up-to-date information is available regarding this revised recommendation, CDC is distributing the following interim polio vaccine information statement for use pending completion of the formal revision process mandated by the NCVIA.     

Notice regarding requirement for annual submission of the quantity of nicotine contained in smokeless tobacco products manufactured, imported, or packaged in the United States. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

This notice establishes a uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products. This protocol was designed to implement the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252), which requires that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product.     

Availability of funds for Community Health Centers (CHCs)--Health Resources and Services Administration. Notice

Under the present Continuing Resolution, Pub. L. 97-377, providing funding for the Department of Health and Human Services, approximately $14 million are available for funding new CHCs and expanding existing CHCs. This notice contains information of interest to prospective applicants for such funding.     

Public health assessments completed. Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). Notice

This notice announces those sites for which ATSDR has completed public health assessments during the period April 1998 through September 1998. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL), and includes sites for which assessments were prepared in response to requests from the public.     

Revised diphtheria, tetanus, and pertussis (DTP/DTaP/DT) vaccine information materials--CDC. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C section 300aa-26), the CDC must develop vaccine information materials that health care providers, either public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 13, 1996, CDC published a notice in the Federal Register (61 FR 48597) seeking public comment on proposed revision of the diphtheria, tetanus, and pertussis vaccine information materials to reflect Food and Drug Administration (FDA) licensure of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP) for administration to infants as young as two months of age. The 60-day comment period ended on November 12, 1996. Following review of the comments submitted and consultation as required under the law, CDC has finalized the revised diphtheria, tetanus, and pertussis vaccine information materials. Those final materials are contained in this notice.     

Clinical studies of safety and effectiveness of orphan products; availability of grants; request for applications. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Notice

The Food and Drug Administration (FDA) is announcing changes to its Orphan Products Development (OPD) grant program for fiscal year (FY) 2000. The previous announcement of this program, which was published in the Federal Register of August 5, 1998 (63 FR 41855), is superseded by this announcement. In the future, a new announcement will be published annually.     

Medicare, Medicaid, and CLIA programs; extension of certain effective dates for clinical laboratory requirements under CLIA. Centers for Disease Control and Prevention (CDC) and Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department to revise quality control requirements and establish the qualification requirements necessary for individuals with doctoral degrees to serve as directors of laboratories performing high complexity testing. These effective date extensions do not reduce the current requirements for quality test performance.     

Cooperative agreement with Policy Research, Inc., to continue the National GAINS Center for People with Co-Occurring Disorders in the Justice System. Center for Substance Abuse Treatment (CSAT) and Center for Mental Health Services (CMHS), Substance Abuse and Mental Health Services Administration (SAMHSA), HHS

This notice is to inform the public of a planned $1,100,000 cooperative agreement award to Policy Research, Inc., to support the National GAINS Center for People with Co-occurring Disorders in the Justice System. CSAT and CMHS will make this award if the application is recommended for approval by the initial review group and the CSAT and CMHS National Advisory Councils. This is not a formal request for applications; assistance will be provided only to Policy Research, Inc. The purpose of the award is to support developing knowledge, conducting analyses of state-of-the-art practices, and disseminating and transferring information related to treating and managing persons in the justice system who are dually diagnosed with substance abuse and mental disorders. The GAINS Center promotes effective solutions by gathering information, assessing what works, interpreting the facts, networking with key stakeholders, and stimulating change. Eligibility for this program is limited to Policy Research, Inc., a non-profit corporation which operates the National GAINS Center. The GAINS Center has been federally funded by SAMHSA through the National Institute of Corrections/Department of Justice. This resource center has established, on a national level, a locus for the collection and dissemination of information about effective mental health and substance abuse services for people with co-occurring disorders in the justice system. The Center gathers information designed to influence the range and scope of mental health and substance abuse services provided in the justice system, tailors these materials to the specific needs of localities, and provides technical assistance to help them plan, implement, and operate appropriate, cost-effective programs. SAMHSA, for administrative reasons, can no longer fund the Center in this fashion because the former funding mechanism is no longer available. Therefore, SAMHSA will fund the project directly to complete the originally approved term of 5 years. An award to Policy Research, Inc., will enable the GAINS Center to build upon prior work and current activities underway in its work plan. This conversion to direct SAMHSA (CSAT and CMHS) funding will permit several important projects to be completed.     

Medicare and Medicaid programs; mandatory use, collection, encoding, and transmission of Outcome and Assessment Information Set (OASIS) for home health agencies. Health Care Financing Administration (HCFA), HHS. Notice

This notice announces to home health agencies (HHAs), State survey agencies, Medicare and Medicaid beneficiaries, software vendors, and the general public changes to and effective dates for OASIS implementation. This notice announces the effective dates for the mandatory use, collection, encoding, and transmission of OASIS data for all Medicare/Medicaid patients receiving skilled services. For non-Medicare/non-Medicaid patients receiving skilled services, there will be no encoding and transmission until further notice, but HHAs must conduct comprehensive assessments and updates at the required time points. For patients receiving personal care only services, regardless of payor source, we are delaying the requirements regarding OASIS use, collection, encoding, and transmission until further notice. We expect to begin implementation of OASIS for non-Medicare/non-Medicaid patients receiving skilled care and for patients receiving personal care only services in the Spring of 2000. A separate Federal Register notice will be published with instructions at that time. In addition, software changes described at the end of this notice are of interest to software vendors and HHAs. Also, a companion notice concerning the OASIS System of Records (SOR) is published elsewhere in this Federal Register and is available via the HCFA Internet site (http://www.hcfa.gov).     

Order for transitional class III devices; submission of safety and effectiveness information under section 520(1)(5)(A) of the Federal Food, Drug, and Cosmetic Act--FDA. Notice

The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of transitional class III devices to submit to FDA a summary of, and a citation to, any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i). This is the first step in the process of determining the appropriate classification of transitional devices under the Safe Medical Devices Act of 1990.