Consultation with state and local officiaLs prior to awarding community health center grants--PHS. Notice

Section 1923 of the Public Health Service (PHS) Act (42 U.S.C. 300y-2) requires that if a State does not apply for a Primary Care Block Grant under section 1924 of the PHS Act (42 U.S.C. 300y-3), or does not qualify for such a grant, the Secretary of Health and Human Services will use those funds not allotted to States participating in the block grant to make grants under section 330 of the PHS Act (42 U.S.C. 254c) to individual community health centers (CHCs). Section 1923 also requires that the Secretary consult with the chief executive officer of the State and with appropriate local officials before making such grants for community health centers in a State. This notice describes the manner in which the Health Resources and Services Administration (HRSA) will fulfill the requirement for consultation. In addition, it solicits comments from local officials regarding CHCs in their areas.     

Designation of medically underserved populations and areas--HRSA. Notice

Under the provisions of section 330(b)(6) of the Public Health Service (PHS) Act, 42 U.S.C. 254c(b)(6), as amended by Pub. L. 99-280, the Governors of the States of Hawaii and Maine have asked the Secretary of Health and Human Services (HHS) to designate specific populations within their States as medically underserved populations (MUPs). Also, under section 330(b)(3) of the PHS Act, certain geographic areas in the States of Missouri, Nebraska, South Carolina, South Dakota, and Washington have been proposed for designation as medically underserved areas (MUAs). This notice provides an opportunity for State and local officials, State organizations representing Community Health Centers, and other interested parties in the above-mentioned States to provide recommendations and to comment on the proposals to designate as medically underserved the areas and populations described in this notice.     

Mental health and substance abuse emergency response criteria. Final rule

Section 3102 of the Children's Health Act of 2000, Pub. L. 106-310, amends section 501 of the Public Health Service (PHS) Act (42 U.S.C. 290aa) to add a new subsection (m) entitled "Emergency Response." This newly enacted subsection 501(m) authorizes the Secretary to use up to, but no more than, 2.5% of all amounts appropriated under Title V of the PHS Act, other than those appropriated under Part C, in each fiscal year to make "noncompetitive grants, contracts or cooperative agreements to public entities to enable such entities to address emergency substance abuse or mental health needs in local communities." Because Congress believed the Secretary needed the ability to respond to emergencies, it exempted any grants, contracts, or cooperative agreements authorized under this section from the peer review process. See section 501(m)(1) of the PHS Act. Instead, the Secretary is to use an objective review process by establishing objective criteria to review applications for funds under this authority.     

Availability of funds for home health services and training--HRSA

The Health Resources and Services Administration (HRSA) announces that funds are available for grants and loans for the development and expansion of home health programs and services. Public Law (Pub. L.) 98-139, the Labor, Health and Human Services, and Education Appropriations Act of 1984, signed on October 31, 1983, appropriates $5 million under section 339 of the Public Health Service (PHS) Act (42 U.S.C. 255) to provide home health services and for the training of paraprofessionals to provide home health services. This notice contains information of interest to prospective applicants for such funding.     

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.     

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.     

Privacy Act of 1974; proposed major alterations to an existing system of records--Public Health Service. Notice of proposed major alterations

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing a notice proposing major alterations in the Privacy Act system of records entitled "Grants Act system of records entitled "Grants: Research, Research Training, Research Scientist Development, Education, Demonstration, Fellowships, Clinical Training, Community Services, Cooperation Agreements, "HHS/ADAMHA/OA, 09-03-0027. The system contains the official documentation of the grant programs of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). The proposed alterations are necessary to ensure compliance with recently added provisions in the Public Health Service Act (PHSA). Section 303 (42 U.S.C 242a), concerning clinical training awardees' payback obligations.     

Notice regarding Section 602 of the Veterans Health Care Act of 1992; new drug pricing--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act ("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 Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final guidelines regarding new drug pricing.     

State offices of rural health grant program--HRSA. Notice of availability of funds

The Office of Rural Health Policy, Health Resources and Services Administration (HRSA), announces that applications are being accepted for matching grants to States for the purpose of improving health care in rural areas through the continued operation of State Offices of Rural Health. This program is authorized by section 338J of the Public Health Service Act 42 U.S.C. 254r. Awards will be made from funds appropriated under Public Law 105-78 (HHS Appropriations Act for Fiscal Year 1998). Approximately $3.0 million will be available to support 50 grants in fiscal year (FY) 1998.     

Notice regarding section 602 of the Veterans Health Care Act of 1992 inclusion of outpatient hospital facilities--PHS. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992" (the "Act"), enacted section 340B of the Public Health Service Act ("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 (the "Agreement") with the Secretary, Department of Health and Human Services, in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the amount determined under a statutory formula. Section 340B(a)(4) lists the entities eligible to receive discount outpatient drug pricing (i.e., certain disproportionate share hospitals (DSHs) and PHS grantees). The definition of a disproportionate share hospital found in section 340B(a)(4)(L) provides criteria to determine which such hospitals are eligible to participate in the program. However, the definition does not include criteria to determine which outpatient facilities (including off-site or satellite clinics) working in conjunction with the eligible hospital would be considered part of the hospital for purposes of eligibility for section 340B drug discounts. The Office of Drug Pricing, which administers this program with PHS, is proposing certain procedures to determine which outpatient hospital facilities are included as part of an eligible disproportionate share hospital.     

Countermeasures Injury Compensation Program (CICP): administrative implementation, interim final rule. Interim final rule with request for comments

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this interim final rule with request for comments in order to establish administrative policies, procedures, and requirements for the CICP. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary is seeking public comments on this interim final rule.     

Availability of information to the public under the Freedom of Information Act; redelegation of authority--Office of the Secretary, HHS. Final regulation

The Department of Health and Human Services hereby amends its regulation implementing the Freedom of Information Act. This revision designates officials who shall have responsibilities for determining whether records must be withheld from disclosure, or released, under provisions of the Act (5 U.S.C. 552).     

Notice regarding section 602 of the Veterans Health Care Act of 1992--rebate option--HRSA. Final 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 inform interested parties of the final guidelines recognizing a rebate option for State AIDS Drug Assistance Programs (ADAPs) receiving funds under Title XXVI of the PHS Act as an optional alternate means of accessing section 340B discount pricing.     

Availability of funds to provide health services in the Pacific Basin--HHS. Notice of availability of funds

The Health Resources and Services Administration (HRSA) announces that up to $331,000 is available under section 301 of the Public Health Service (PHS) ACT 42 U.S.C. 241, for funding public and non-profit private entities for projects to build capacity and improve health services and systems, particularly preventive health services, in the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands and the Republic of Palau and to provide technical assistance relative to such projects. In recognition of the extent of funding available, these funds will be available only to continue activities currently receiving funds under the section 301 Pacific Initiative grant authority. HRSA will entertain applications from current grantees for supplemental grants to modify project activities, and from eligible organizations for competing continuation grant awards to extend project activities.     

Grants to states for construction or acquisition of state home facilities--VA. Final regulations

The Department of Veterans Affairs (VA) is amending its medical care regulations, Grants to States for Construction or Acquisition of State Home Facilities (38 CFR part 17), to implement section 206 of the Veterans' Benefits and Services Act of 1988 enacted on May 20, 1988. This section changes from July 1 to August 15, the date on which VA will determine the priority of applications for construction or acquisition grants for State Extended Care Facilities for purposes of the priority list. Section 206 also provides the Secretary authority to conditionally approve an application and obligate funds for a grant is the Secretary determines that the State can meet all remaining Federal requirements within 90 days. At the same time, VA is updating the States home grant standards and veteran population of the various States set forth in these regulations. These revisions will assist the States in meeting deadlines for the priority list and subsequent grant awards.     

Lists of designated primary medical care, mental health, and dental health professional shortage areas--HRSA. Notice

This notice provides lists of all areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of September 30, 1996. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act.     

Lists of designated primary medical care, mental health, and dental health professional shortage areas--HRSA. Notice

This notice provides lists of all areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of June 15, 1995. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act.     

List of designated primary medical care, mental health, and dental health professional shortage areas--HRSA. Notice

This notice provides lists of all areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of March 31, 1997. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 322 of the Public Health Service (PHS) Act.     

Medicaid program; demonstration proposals pursuant to section 1115(a) of the Social Security Act; policies and procedures--HCFA and ACF. Public notice

This public notice informs interested parties of (1) the principles the Department of Health and Human Services ordinarily will consider when deciding whether to exercise its discretion to approve or disapprove demonstration projects under the authority in Section 1115(a) of the Social Security Act, 42 U.S.C. section 1315(a); (2) the kinds of procedures the Department would expect States to employ in involving the public in the development of proposed demonstration projects under Section 1115; and (3) the procedures the Department ordinarily will follow in reviewing demonstration proposals. The principles and procedures described in this public notice are being provided for the information of interested parties, and are not legally binding on the Department of Health and Human Services. This notice does not create any right or benefit, substantive or procedural, enforceable at law or equity, by any person or entity, against the United States, its agencies or instrumentalities, the States, or any other person.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS. Notice of proposed rulemaking

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, proposes to amend the regulations governing certificates of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The proposed amendments would accomplish two tasks: (1) Implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and (2) reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Secretary's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth proposed changes to the requirements for satisfactory certificate of need programs. Interested persons are invited to submit written comments and recommendations concerning these proposed rules as well as suggestions for alternative methods of implementing any of the provisions of the amendments that affect the requirements for certificate of need programs.