Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing the format in which certain labeling is required to be submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), supplements, and annual reports. The final rule requires that certain labeling content be submitted electronically in a form that FDA can process, review, and archive. Submitting the content of labeling in electronic format will simplify the drug labeling review process and speed up the approval of labeling changes.     

Request for comments: technical assistance to rural hospitals--HRSA. Notice: request for comments

The Health Resources and Services Administration (HRSA), Office of Rural Health Policy (ORHP), is interested in obtaining public comments and suggestions to assist the Office in planning a program of technical assistance to rural hospitals. The ORHP is anticipating that funds may become available in Fiscal Year 1991 for technical assistance to rural hospitals. The ORHP invites comments on the needs of rural hospitals for technical assistance and support.     

Hazardous waste management system--Environmental Protection Agency. Notice of regulatory reform actions; request for comments

In response to Executive Order 12291 and the President's Task Force on Regulatory Relief, the Environmental Protection Agency is reviewing and reassessing the hazardous waste regulations developed under the Resource Conservation and Recovery Act (RCRA). A variety of activities are underway that will simplify procedures and reduce paperwork, modify existing regulations to make them more workable and cost effective, and control new wastes and new processes. The purpose of this notice is to inform the public of these activities and invite comments on the general approaches being taken.     

Erythrityl tetranitrate; drug efficacy study implementation; revocation of exemption; opportunity for a hearing--FDA. Notice

The Food and Drug Administration (FDA) is revoking the temporary exemption that has allowed single-entity coronary vasodilator drug products containing erythrityl tetranitrate to remain on the market beyond the time limits scheduled for implementation of the Drug Efficacy Study. FDA is announcing that the products lack substantial evidence of effectiveness and is offering an opportunity for a hearing on a proposal to withdraw approval of any applicable new drug applications (NDA's) or abbreviated new drug applications (ANDA's).     

Medicare program: request for public comments on implementation of the Medicare+Choice program, and notice of timeframes for submission of applications for contracts--HCFA. Notice of intent to regulate; solicitation of comments

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice program. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plans that contract with us. The BBA directs the Secretary to publish by June 1, 1998, regulations establishing standards for the Medicare+Choice program. We have already received comments and inquiries from the public on a number of issues associated with the Medicare+Choice program. This document solicits further public comments on issues related to implementation of the Medicare+Choice program. We intend to consider these comments as we develop an interim final rule to implement the Medicare+Choice program. This document also includes preliminary information regarding application procedures for organizations that intend to contract with us to participate in the Medicare+Choice program. This document also informs the public of a meeting to discuss the Medicare+Choice program.     

Premerger notification: reporting and waiting period requirements--FTC. Notice of adoption of formal interpretation and request for comments

The Premerger Notification Office ("PNO") of the Federal Trade Commission ("FTC"), with the concurrence of the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice ("DOJ"), is adopting a Formal Interpretation of the Hart-Scott-Rodino Act, which requires certain persons planning certain mergers, consolidations, or other acquisitions to report information about the proposed transactions to the FTC and DOJ. The Interpretation concerns the reportability of certain transactions involving a Limited Liability Company ("LLC"), a relatively new form of entity authorized by state statutes. Under the Interpretation, the formation of an LLC will be reportable if it will unite two or more pre-existing businesses under common control. Similarly, acquisitions of existing LLC membership interests will be reportable if they would have the effect of uniting two or more pre-existing businesses under common control.     

Medical Radiation Advisory Committee; request for nominations for membership--FDA. Notice

The Food and Drug Administration (FDA) is requesting nominations for membership on the Medical Radiation Advisory Committee. There is currently one vacancy on the committee and there will be three additional vacancies on June 30, 1985.     

Medicare program: request for public comments on implementation of risk adjusted payment for the Medicare+Choice program and announcement of public meeting--HCFA. Solicitation of comments; announcement of meeting

This notice solicits further public comments on issues related to the implementation of risk adjusted payment of Medicare+Choice organizations. Section 1853(a)(3) of the Social Security Act (the Act) requires the Secretary to implement a risk adjustment methodology that accounts for variation in per capita costs based on health status and demographic factors for payments no later than January 1, 2000. The methodology is to apply uniformly to all Medicare+Choice plans. This notice outlines our proposed approach to implementing risk adjusted payment. In order to carry out risk adjustment, section 1853(a)(3) of the Act also requires Medicare+Choice organizations, as well as other organizations with risk sharing contracts, to submit encounter data. Inpatient hospital data are required for discharges on or after July 1, 1997. Other data, as the Secretary deems necessary, may be required beginning July 1998. The Medicare+Choice interim final rule published on June 26, 1998 (63 FR 34968) describes the general process for the collection of encounter data. We also included a schedule for the collection of additional encounter data. Physician, outpatient hospital, skilled nursing facility, and home health data will be collected no earlier than October 1, 1999, and all other data we deem necessary no earlier than October 1, 2000. Given any start date, comprehensive risk adjustment will be made about three years after the year of initial collection of outpatient hospital and physician encounter data. Comments on the process for encounter data collection are requested in that interim final rule. We intend to consider comments received in response to this solicitation as we develop the final methodology for implementation of risk adjustment. This notice also informs the public of a meeting on September 17, 1998, to discuss risk adjustment and the collection of encounter data. The meeting will be held at the Health Care Financing Administration headquarters, located at 7500 Security Boulevard, Baltimore, MD, beginning at 8:30 a.m. Additional materials on the risk adjustment model will be available on or after October 15, 1998, and may be requested in writing from Chapin Wilson, Health Care Financing Administration, Department of Health and Human Services, 200 Independence Avenue, S. W., Room 435-H, Washington, DC 20201.     

Federal universal service support mechanisms--FCC. Proposed rule; request for comments

In this document, the Commission seeks comment on the Report and Proposed Plan of Reorganization (Plan) filed on July 1, 1998 by the Universal Service Administrative Company (USAC), the Schools and Libraries Corporation (SLC), and the Rural Health Care Corporation (RHCC). The Plan proposes a revised adminstrative structure of the federal universal service support mechanisms. RHCC filed a Separate Statement of the Rural Health Care Corporation and Request for Three Changes in the Plan, dissenting from certain provisions of the proposed Plan. In this document, the Commission also seeks comment on other issues regarding the administration of the federal universal service support mechanisms, including processes for Commission review of actions by USAC, SLC, and RHCC.     

Drug labeling; sodium labeling for over-the-counter drugs. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the regulations for sodium labeling for over-the-counter (OTC) drug products by extending the sodium content labeling requirement to rectal drug products containing sodium phosphate/sodium biphosphate (sodium phosphates). FDA is taking this action because people with certain medical conditions are at risk for an electrolyte imbalance to occur when using rectal sodium phosphates products. Serious adverse events and deaths have occurred because of the high level of sodium present in these products. This final rule is part of FDA's ongoing review of OTC drug products.     

Proposed procedural regulations--Equal Employment Opportunity Commission. Proposed regulations; request for comments

The Equal Employment Opportunity Commission is publishing for comment proposed procedural regulations (29 CFR Part 1626). These regulations advise the public as to the procedures the Commission proposes to follow in processing charges and issuing interpretations and opinions under the Age Discrimination in Employment Act. These regulations will complement the Commission's existing procedural regulations under Title VII of the Civil Rights Act of 1964.     

Medical devices; illustrative and designated lists for device tracking--FDA. Final rule and request for comments

The Food and Drug Administration (FDA) is amending the medical device tracking regulations to add the temporo-mandibular joint prostheses to the illustrative list of devices and the penile inflatable implant to the list of devices designated for tracking. These devices are being added to the illustrative and designated device lists based on the significance of the risk to health posed by their use. This action requires manufacturers to track these devices after distribution so that they can be located in the event of a recall or patient notification action. FDA requests comments on these changes. Elsewhere in this issue of the Federal Register, the agency is announcing notification of the change of status of the device tracking regulations and is suspending the effective date of the regulations until August 29, 1993.     

Clinical studies of safety and effectiveness of orphan products; availability of grants; request for applications--FDA. Notice

The Food and Drug Administration (FDA) is announcing changes to its Orphan Products Development (OPD) grant program for fiscal year (FY) 1999. The previous announcement of this program, which was published in the Federal Register of July 9, 1997, is superseded by this announcement. In the future, a new announcement will be published annually.     

Medicare program; establishment of the Medicare Coverage Advisory Committee and request for nominations for members. Notice

This notice announces the establishment of the Medicare Coverage Advisory Committee that will advise the Secretary of Health and Human Services and the Administrator of the Health Care Financing Administration, as requested by the Secretary, whether medical items and services are reasonable and necessary under title XVIII of the Social Security Act. This notice requests nominations for members for the Committee. This notice also announces the signing by the Secretary on November 24, 1998 of the charter establishing the Committee. This charter ends at close of business on November 23, 2000 unless renewed by the Secretary.     

Diagnostic x-ray equipment performance standard; request for comments and information--FDA. Advance notice of proposed rulemaking

The Food and Drug Administration (FDA) is announcing its intention to propose amendments to the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to address changes in the technology and use of radiographic and fluoroscopic systems. The agency is issuing this advance notice of proposed rulemaking (ANPRM) in accordance with its policy of early public disclosure of rulemaking activities. The FDA is soliciting comments and information from interested persons concerning the subject matter of the proposed amendments.     

Adjustment of status; certain H-1 nonimmigrant nurses--INS. Interim rule with request for comments

This interim rule implements section 162(f) of the Immigration Act of 1990 (IMMACT 90), Public Law 101-649, November 29, 1990. The interim rule establishes procedures for the adjustment of status to that of lawful permanent resident for certain alien nurses, their spouses and children.