Indian health--PHS. Proposed rule

The Department of Health and Human Services (HHS) is proposing to make technical amendments to Indian Health Service (IHS) grant regulations to make them conform to HHS regulations on grant administration, thereby eliminating duplication and conflict within the regulations.     

Quality mammography standards--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography that published in a document entitled "Quality Mammography Standards." The purpose of these amendments is to eliminate a conflict between the mammography regulations, which must be followed by all facilities performing mammography, and FDA's Electronic Product Radiation Control (EPRC) performance standards, which establish radiation safety performance requirements for x-ray units, including mammographic systems.     

Medical: advance healthcare planning--VA. Proposed rule

This document proposes to amend the VA medical regulations to codify VA policy regarding advance healthcare planning. The proposed rule sets forth a mechanism for the use of written advance directives, i.e., a VA Living Will, a VA durable power of attorney for health care, and a state-authorized advance directive. The proposed rule also sets forth a mechanism for honoring verbal or nonverbal instructions from a patient when the patient is admitted to care when critically ill and loss of capacity may be imminent and the patient is not physically able to sign an advance directive form, or the appropriate form is not readily available. This is intended to help ensure that VA acts in compliance with patients' wishes concerning future healthcare.     

Procurement forms and administrative matters--HHS. Proposed rule

The Office of the Secretary, Department of Health and Human Services, is proposing to amend 41 CFR Part 3-50, Administrative matters, by adding a new subpart, 3-50.8, Determination of Adequacy of Contractors' Accounting and Billing Systems and Preparation of Invoices. This new subpart will establish uniform Departmental billing and financial reporting requirements for inclusion in cost-reimbursement type contracts. The objective of the new subpart are: (a) Streamlining the reporting of financial data; (b) establishing the requirements for determination of the adequacy of a contractor's accounting and billing system; and (c) establishing guidelines for the preparation of invoices for cost-reimbursement type contracts. Part 3-16, Procurement Forms, will be amended by the addition of three subsections to Subpart 3-16.9, Illustration of Forms. These subsections illustrate the financial reporting form and contain instructions for filling out the form and preparing invoices under cost reimbursement type contracts. When issued as a final rule, this regulation will supersede Procurement Circular HEW-78.1, Billing Instructions and Financial Reporting Requirements dated April 12, 1978, except for Section 3-50.803(b). Paragraph 3-50.803(b) has been superseded by Procurement Circular HHS 82.04, Prompt Payment, dated October 1, 1982.     

General and procurement by negotiation--DHHS. Proposed rule

The Office of the Secretary, Department of Health and Human Services, is proposing to amend 41 CFR 3-1.453, Establishment of cost rates, to identify officials delegated authority to approve indirect cost rates and special rates for commercial organizations. Part 3-3, Procurement by negotiation, is proposed to be amended by adding a new Subpart 3-3.7. Negotiated overhead rates, which sets forth policies and procedures concerning the approval of indirect cost rates and special rates for use in the pricing and administration of contracts.     

New drug and antibiotic regulations--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to revise its regulations governing the approval for marketing of new drugs and antibiotic drugs for human use. FDA is taking this action to improve the efficiency of the agency's drug approval process and to improve the agency's dealings with applicants for marketing approval of new drugs and antibiotic drugs, while still maintaining the high level of public health protection the drug approval process now provides. The improvements will help applicants prepare and submit higher quality applications and permit FDA to review them more efficiently and with fewer delays. This will benefit consumers through earlier availability of drugs and benefit applicants by permitting earlier marketing of new drugs and antibiotics. This action is one part of a larger effort by FDA to review all facets of the agency's drug approval process.     

Security and electronic signature standards--HCFA. Proposed rule

This rule proposes standards for the security of individual health information and electronic signature use by health plans, health care clearinghouses, and health care providers would use the security standards to develop and maintain the security of all electronic individual health information. The electronic signature standard is applicable only with respect to use with the specific transactions defined in the Health Insurance Portability and Accountability Act of 1996, and when it has been determined that an electronic signature must be used. The use of these standards would improve the Medicare and Medicaid programs, and other Federal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general. This rule would implement some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

Medicare program; ambulance services--HCFA. Proposed rule

This proposed rule would update and revise HCFA's policy on coverage of ambulance services. It would base Medicare coverage and payment for ambulance services on the level of medical services needed to treat the beneficiary's condition. It also clarifies Medicare policy on coverage of non-emergency ambulance services for Medicare beneficiaries.     

Protection of human subjects--Department of Energy. Proposed rule

Executive Order 12044 sets forth a program of regulatory reform to be followed by all executive departments. One element of that program is periodic review of existing regulations. The Department of Energy is committed to review all of its existing regulations within five years, on schedule set forth in the Federal Register for May 8, 1980, 45 FR 30448. As part of that commitment, the Department has reexmained the regulations contained in 10 CFR Part 745. These regulations deal with the protection of human subjects in research activities supported by the Department. In this notice, we are proposing regulations that will supersede the existing requirements. These proposed regulations are intended substantially to duplicate the policies and procedures proposed by the Department of Health and Human Services on August 14, 1979 (44 FR 47688). The primary responsibility for adequate review and approval to protect human subjects of research activities sponsored by the Department of Energy is placed on the institution that receives, or is accountable to the Department, for the funds awarded.     

Deregulation of mobile customer premises equipment--FCC. Proposed rule

In this Notice, the Commission proposes to deregulate all mobile telephone customer premises equipment (CPE). In the Second Computer Inquiry, the Commission directed common carriers to offer CPE on a nontariffed basis separate from their transmission offerings. However, the Commission expressly excluded mobile CPE from the scope of its decision. In this proceeding, the Commission will consider whether to conform the treatment of mobile CPE with its treatment of all other CPE.     

Verification of eligibility for public benefits--INS. Proposed rule

This rule amends the Immigration and Naturalization Service ("Service") regulations by establishing a new part requiring certain entities that provide Federal public benefits (with certain exceptions) to verify, by examining alien applicants' evidence of alien registration and by using a Service automated verification system that the applicants are eligible for the benefits under welfare reform legislation. The rule also sets forth procedures by which a State or local government can verify whether an alien applying for a State or local public benefit is a qualified alien, a nonimmigrant, or an alien paroled into the United States for less than 1 year, for purposes of determining whether the alien is eligible for the benefit. In addition, the rule establishes procedures for verifying the U.S. nationality of individuals applying for benefits in a fair and nondiscriminatory manner.     

Medicare program; additional supplier standards--HCFA. Proposed rule

This proposed rule would establish additional standards for an entity to qualify as a Medicare supplier for purposes of submitting claims for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). This proposed rule would establish additional standards that must be satisfied before a DMEPOS supplier could receive payment from the Medicare program. The Social Security Act Amendments of 1994 require that a DMEPOS supplier meet standards related to compliance with State and Federal licensure requirements, maintaining a physical facility on an appropriate site, proof of appropriate liability insurance, and other standards the Secretary may specify.     

HUD board and care home regulations--HUD. Proposed rule

This rule would permit HUD to provide mortgage insurance for the construction or rehabilitation of board and care homes, as authorized under section 437 of the Housing and Urban-Rural Recovery Act of 1983, Pub. L. 98-181.     

Debarment, suspension, and ineligibility--DHHS. Proposed rule

The Office of the Secretary, Department of Health and Human Services, is proposing to amend 41 CFR 3-1.6, Debarred, Suspended, and Ineligible Bidders, to implement the provisions of Federal Procurement Regulations [FPR] Temporary Regulation 65, Debarment, Suspension and Ineligibility of Government Contractors.     

Medicaid program; Medicaid managed care--HCFA. Proposed rule

This proposed rule would amend the Medicaid regulations to allow the States greater flexibility by giving them the option to require Medicaid recipients to enroll in managed care entities without obtaining waivers. These revisions, which are authorized by the Balanced Budget Act of 1997, would establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services. They would eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. They would also permit State agencies to amend their State plans to require enrollment in managed care organizations subject to certain conditions, including limits on whose enrollment can be mandated, and a requirement for beneficiary choice. In addition, this rule would extend most of these new requirements to prepaid health plans.     

National standard health care provider identifier--HCFA. Proposed rule

This rule proposes a standard for a national health care provider identifier and requirements concerning its use by health plans, health care clearinghouses, and health care providers. The health plans, health care clearinghouses, and health care providers would use the identifier, among other uses, in connection with certain electronic transactions. The use of this identifier would improve the Medicare and Medicaid programs, and other Federal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general, by simplifying the administration of the system and enabling the efficient electronic transmission of certain health information. It would implement some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

Medical devices; investigational device exemptions--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the Investigational Device Exemptions (IDE) regulation. The proposed regulatory changes are intended to reflect amendments to the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). These amendments provide that the sponsor of an IDE may modify the device and/or clinical protocol, without approval of a new application or supplemental application, if the modifications meet certain criteria and if notice is provided to FDA within 5 days of making the change. The proposed rule also defines the credible information to be used by sponsors to determine if the criteria are met.     

License term for medical use licenses--NRC. Proposed rule

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.     

Electronic Freedom of Information Act; implementation--USIA. Proposed rule

This rule establishes requirements and conditions necessary for the implementation of the new Electronic Freedom of Information Act (FOIA) Amendments of 1996, 5 U.S.C. 552, as amended by Pub. L. 104-231. This addition to the present regulation will establish criteria that will enable FOIA requesters to better understand how documents of the Agency are maintained and handled electronically.