Notice regarding HRSA grant requirement--participation in the 340B drug pricing program--HRSA. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to request comments on a proposed grant award requirement in which all entities, except those entities which fall within excepted categories, that receive HRSA grants listed in section 340B(a)(4) and that purchase or reimburse for covered outpatient drugs must participate in the 340B Drug Pricing Program, or demonstrate good cause for nonparticipation. When the Prime Vendor program is operational, HRSA intends to publish a second Federal Register notice proposing an expansion of the grant award requirement to include participation in the Prime Vendor Program.     

Cessation of services to terminated Utes--Indian Health Service. Notice

The IHS is correcting a regional policy of providing services to descendants of terminated Utes. The regional practice of deeming descendants of terminated Utes eligible for IHS services has been determined to be contrary to the purpose of the Ute Termination Act 25 U.S.C. 677, as we interpret that Act, and therefore, descendants of such terminated Utes are outside the scope of authorized IHS services.     

和谐社会视角下的城市新型社区居民参与问题研究

本文依据和谐社会建设对城市新型社区建设的要求，分析了城市新型社区居民参与的形式、参与的途径及存在的主要问题，对和谐社会视角下城市新型社区居民参与问题提出了一些对策与建议。提出培育和增强居民参与社区建设的意识、培育和发展社区自治组织、扩展居民参与渠道、实现监督方式的多样化是实现真正意义上社区自治的有效途径。     

Letter to manufacturers of blood establishment computer software products--FDA. Notice

The Food and Drug Administration (FDA) is publishing a letter sent to known manufacturers of blood establishment computer software products. In the letter, FDA advised these manufacturers that it considers these computer software products to be devices under the Federal Food, Drug, and Cosmetic Act (the act) because these products aid in the prevention of disease by identifying unsuitable donors and preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing use. The letter, accompanied by a registration package and device listing was intended to notify manufacturers of the requirements of the act, to facilitate registration of these manufacturers as medical device manufacturers, and to further ensure the safety of the blood supply.     

Changes to Medicare Secondary Payer (MSP) provisions--HCFA. Notice

This notice describes how subsections 6202(b), (c), and (e) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) affect the Medicare Program These subsections: Create uniform rules for computing Medicare secondary payments for all MSP situations; Exempt from the MSP provisions services performed for a religious order by members of the order who take a vow of poverty; Prohibit group health plans (GHPs) from "taking into account" that an individual is entitled to Medicare when Medicare is the secondary payer; Prohibit GHPs from differentiating, in the services they provide, between individuals with end-stage renal disease (ESRD) and other individuals covered by the plan; Require that GHPs of employers of 20 or more employees provide the same benefits under the same conditions to employees age 65 or older and employees' spouses age 65 or older as they provide to employees and spouses under age 65; Impose a 25 percent excise tax on contributions that employers and employee organizations make to nonconforming GHPs, i.e., plans that do not comply with the MSP provisions; Extend to all MSP situations the Federal Government's right to take legal action to collect double damages if a primary plan fails to comply with the Medicare secondary payment requirements of the law; Make the provisions for special enrollment periods for the disabled parallel to those in effect for the working aged. The statutory changes made by subsections 6202(b), (c), and (e) can be put into effect without first issuing regulations because it is clear on the face of the statute what the Congress intended.(ABSTRACT TRUNCATED AT 250 WORDS)     

Notice regarding Federally Supported Health Centers Assistance Act of 1992--HRSA. Notice

The Secretary of Health and Human Services (the "Secretary"), in consultation with the Attorney General, provides the following notice regarding Public Law 102-501, the "Federally Supported Health Centers Assistance Act of 1992" (the "Act"). The Act provides for liability protection for certain health care professionals and entities. This notice sets forth information whereby an entity or a person can determine when, and the extent to which, it is deemed to be an entity as described in the Act.     

Medical devices; device tracking; new orders to manufacturers--FDA. Notice

The Food and Drug Administration (FDA) is announcing that the agency has issued new orders to manufacturers of devices that were subject to tracking. These new orders became effective on February 19, 1998, and require manufacturers to continue tracking the devices under the revised tracking provisions of the recently enacted Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA allows the agency discretion in issuing orders to manufacturers to track devices that meet certain criteria. FDA is soliciting comments on what factors should be considered in exercising its discretion in determining whether the agency should not track a particular device, even though it meets the statutory criteria. FDA specifically is requesting comments on whether there are factors that FDA should consider in exercising its discretion in releasing certain devices listed in this notice from tracking requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance that addresses device tracking under FDAMA, including the application of certain requirements under the current tracking regulations.     

Notice regarding the Federally Supported Health Centers Assistance Act of 1992--HRSA. Notice

On May 8, 1995, the Secretary of Health and Human Services published a final rule implementing certain provisions of the Federally Supported Health Centers Assistance Act of 1992 (the Act). The Act provides for liability protection for certain grantees of the Public Health Service and for certain individuals associated with these grantees. The Health Resources and Services Administration is the agency within the Department responsible for administering certain aspects of the Act. This notice provides further guidance regarding the final rule.     

Federal financial participation in state assistance expenditures--HHS. Notice

The Federal Percentages and Federal Medical Assistance Percentages for Fiscal Year 1993 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 1992, through September 30, 1993. This notice announces the calculated "Federal percentages" and "Federal medical assistance percentages" that we will use in determining the amount of Federal matching in State welfare and medical expenditures for programs under titles I, IV-A, IV-E, IV-F, X, XIV, XVI (AABD) and XIX. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. The percentages in this notice apply to State expenditures for assistance payments and medical services (except family planning which is subject to a higher matching rate). The statute provides separately for Federal matching of administrative costs. Sections 1101(a)(8) and 1905(b) of the Act, as revised by section 9528 of Public Law 99-272, require the Secretary of Health and Human Services to publish these percentages each year. The Secretary is to figure the percentages, by formulas described in sections 1101(a)(8) and 1905(b) of the Act, using the Department of Commerce's statistics of average income per person in each State and in the Nation as a whole. The percentages are with upper and lower limits given in those two sections of the Act. The statute specifies the percentages to be applied to Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.(ABSTRACT TRUNCATED AT 250 WORDS)     

Medical care collection or recovery--VA. Notice

In a companion document published in the "Proposed Rules" section of this issue of the Federal Register, we proposed to amend VA's medical regulations concerning collection or recovery by VA for medical care or services provided or furnished to a veteran: (i) For a non-service connected disability for which the veteran is entitled to care (or the payment of expenses of care) under a health-plan contract; (ii) For a non-service connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or (iii) For a non-service connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations insurance. The proposed rule includes methodology for establishing charges for VA medical care or services. Using this methodology, information for calculating proposed charge amounts at individual VA facilities for inpatient facility charges, skilled nursing facility/sub-acute inpatient facility charges, outpatient facility charges, and physician charges is set forth below. If this methodology were adopted subsequently as a final rule, the applicable data in this document, designed for the period August 1998 through September 1999, would be used for the period from the effective date of the final rule through September 1999. Accordingly, interested parties may wish to retain this document for future reference.     

Health maintenance organizations--PHS. Notice, July

This notice sets forth the names, addresses, service areas, and dates of qualification of entities determined by the Secretary to be qualified health maintenance organizations [HMOs]. In addition, this notice reports a service area expansion and name changes of previously qualified HMOs.     

Implementation of Pro-Children Act of 1994--HHS. Notice to prohibit smoking in certain facilities

The Department of Health and Human Services announces the implementation of the Pro-Children Act of 1994, which prohibits smoking in certain facilities in which education, library, day care, health care and early childhood development (including WIC and Head Start) services are provided to children. In accordance with section 1043(d) of the Act, the Secretary of Health and Human Services is publishing the prohibitions which restrict smoking in certain indoor facilities.     

Funding reductions in fiscal year 1982. Health Services Administration. Notice

This notice announces: (1) Factors that the Health Services Administration (HSA) will use in determining which Community Health Center (CHC) projects to fund, and (2) restrictions on the type of project activities that will be eligible for Federal support under the CHC program. a reduced level of authorization of appropriations for section 30 of the Public Health Service (PHS) Act in the recently enacted Omnibus Budget Reconciliation Act of 1981 (Pub. L 97-35) is the reason for the announcement of these factors and restrictions.     

Notice regarding section 602 of the Veterans Health Care Act of 1992 rebate option--HRSA. Notice

Section 602 of Pub. L. 102-585, the "Veterans Health Care Act of 1992", enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to request comments on the proposal of a rebate option for State AIDS Drug Assistance Programs (ADAPs) receiving funds under Title XXVI of the PHS Act.     

Guidance for industry: donor screening for antibodies to HTLV-II; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Donor Screening for Antibodies to HTLV-II." The guidance document provides information regarding human T-lymphotrophic virus type II (HTLV-II) screening tests for Whole Blood and blood components. This guidance document is a further effort of FDA to help ensure a safe blood supply for the United States of America (U.S.).