License terms for medical use licenses--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.     

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.     

New drugs for human use; clarification of requirements for patent holder notification--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations on notice of certification of invalidity or noninfringement of a patent to provide additional methods for new drug and abbreviated new drug applicants to provide notice to patent owners and new drug application (NDA) holders, without removing the existing means. These proposed amendments reflect current business practices and are intended to ensure that notice is provided to patent owners and NDA holders in a timely manner. FDA is also proposing to require certain applicants to submit to FDA a copy of the notice of certification.     

Revised medical criteria for determination of disability, endocrine system and related criteria--SSA. Proposed rule

We are proposing to delete "Obesity," from the listing to adjudicate claims for disability under titles II and XVI of the Social Security Act (the Act) when we evaluate claims of individuals at step 3 of our sequential evaluation process. Current medical and vocational research demonstrates that, while many individuals with obesity are disabled, obesity, in and of itself, is not necessarily determinative of an individual's inability to engage in any gainful activity. Instead, individuals with obesity would have their cases reviewed under the listing for an affected body system(s) or, on a case-by-case basis, at the remaining steps of the sequential evaluation process.     

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.     

Ophthalmic drug products for over-the-counter human use; proposed amendment of final monograph--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) ophthalmic drug products. The amendment adds a new warning and revises an existing warning for ophthalmic vasoconstrictor drug products. These products contain the ingredients ephedrine hydrochloride, naphazoline hydrochloride, phenylephrine hydrochloride, or tetrahydrozoline hydrochloride; and they are used to relieve redness of the eye due to minor eye irritations. This proposal is part of the ongoing review of OTC drug products conducted by FDA.     

Reconsideration of denied claims--VA. Proposed rule

This document proposes to amend the Department of Veterans Affairs' "Medical" regulations by adding a new section to set forth reconsideration procedures available if requested by an individual or entity who made a claim for benefits administered by the Veterans Health Administration and who disagrees with the initial decision denying the claim. It is anticipated that these procedures would not only allow for more reflective decisions at the local level but would also allow some disputes to be resolved without the need for further appeal to the Board of Veterans Appeals.     

Exemption from import/export requirements for personal medical use. Final rule

The Drug Enforcement Administration (DEA) is amending its regulations to expressly incorporate the restrictions on personal use importation imposed by Congress in 1998 and to expand upon those restrictions to curtail the diversion that has continued even after the 1998 congressional amendment. Specifically, DEA is limiting to 50 dosage units the total amount of controlled substances that a United States resident may bring into the United States for legitimate personal medical use when returning from travel abroad at any location and by any means. This regulation will help prevent importation of controlled substances for unlawful use while still accommodating travelers who have a legitimate medical need for controlled substances during their journey.     

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.     

Health insurance reform: standards for electronic transactions--HCFA. Proposed rule

This rule proposes standards for eight electronic transactions and for code sets to be used in those transactions. It also proposes requirements concerning the use of these standards by health plans, health care clearinghouses, and health care providers. The use of these standard transactions and code sets 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 Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

Medical devices; humanitarian use of devices; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing humanitarian use devices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.     

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.