Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Revisions to the general safety test requirements for biological products--FDA. Direct final rule: confirmation in part and withdrawal in part

The Food and Drug Administration (FDA) is confirming in part and withdrawing in part the provisions in the direct final rule that published in the Federal Register of April 20, 1998, to revise the general safety test (GST) requirements for biological products. FDA is confirming the part of the rule about which no significant adverse comment was received and withdrawing the part about which significant adverse comment was received.     

Medicare and state health care programs: fraud and abuse; safe harbors for protecting health plans--Office of Inspector General, HHS. Final rule

In accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this final rule sets forth various standards and guidelines for safe harbor provisions designed to protect certain health care plans, such as health maintenance organizations and preferred provider organizations, under the Medicare and State health care programs' anti-kickback statute. These safe harbor provisions were originally published in the Federal Register on November 5, 1992 in interim final form. In response to the various public comments received, this final rule revises and clarifies various aspects of that earlier rulemaking.     

Medicare program; refinements to geographic adjustment factor values, revisions to payment policies, adjustments to the relative value units (RVUs) under the physician fee schedule for calendar year 1995, and the 5-year refinement of RVUs; correction--HCFA. Correction of final rule with comment period

This document is a second correction to technical errors that appeared in the final rule with comment period entitled "Medicare Program; Refinements to Geographic Adjustment Factor Values, Revisions to Payment Policies, Adjustments to the Relative Value Units (RVUs) Under the Physician Fee Schedule for Calendar Year 1995, and the 5-Year Refinement of RVUs" published in the Federal Register on December 8, 1994. The first correction notice was published in the Federal Register on January 3, 1995 (60 FR 46).     

Health care programs; fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93-- Office of Inspector General, HHS. Final rule and clarification

This final rule clarifies the scope and purpose of the exclusion authority provisions originally set forth in final rulemaking published in the Federal Register on January 29, 1992 (57 FR 3298). That final rule implemented the OIG sanction and civil money penalty (CMP) provisions established through section 2 and other conforming amendments in the Medicare and Medicaid Patient and Program Protection Act of 1987, and other statutory authorities. This clarifying document modifies the final rule to give greater clarity to the original scope of the authorities contained in 42 CFR part 1001. In addition, this rule is providing further clarification to the discovery provision set forth in part 1005 of the regulations.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, other non-profit, and commercial organizations--Department of Commerce. Interim final rule

This interim final rule implements the revisions to the Office of Management and Budget (OMB) Circular A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations" which was published in the Federal Register on November 29, 1993. The revised Circular was developed by an interagency task force for governmentwide use in a model rule format to facilitate regulatory adoption by executive departments and agencies. In the published revised Circular, OMB specified as "required action" that Federal agencies responsible for awarding and administering grants and other agreements to recipients described therein, shall adopt the language of the Circular unless other provisions are required by Federal statute or exceptions or deviations are approved by OMB. This interim final rule adopts the provisions of the Circular and its language to the maximum extent feasible. However, minor changes were made to update the procedures, clarify the language, and make the language apply specifically to the DoC and its operating units. No changes are intended to deviate from the substance of Circular A-110. The Circular covers both grants and cooperative agreements made by Federal agencies and subawards, unless sections of the Circular specifically exclude subrecipients from coverage. Consistent with guidance provided in the Circular, DoC will apply its provisions to grants and agreements with institutions of higher education, hospitals, other nonprofit, and commercial organizations. The provisions of the interim final rule will also apply to foreign governments, organizations under the jurisdiction of foreign governments, and international organizations when appropriate.     

Medicaid program; State share of financial participation--HCFA. Interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. Because of misunderstanding created by certain portions of that rule, we are publishing this interim final rule to withdraw and cancel it and to set forth a clearer interim final rule on donations and taxes.     

Medicare program; home health agencies: conditions of participation--HHS. Correction of final rule

This document corrects technical errors that appeared in the final rule published in the Federal Register on July 18, 1991 [56 FR 32967] entitled "Medicare Program; Home Health Agencies: Conditions of Participation."     

Medicaid program; state share of financial participation--HCFA. Withdrawal of interim final rule with comment

On September 12, 1991, we published in the Federal Register an interim final rule with comment entitled "Medicaid Program; State Share of Financial Participation" (56 FR 46380). It dealt with the use of State taxes and provider donations as the State share of the costs of the Medicaid program. On October 31, 1991, we published a clarifying interim final rule with comment (56 FR 56132), which withdrew and cancelled the September 12, 1991, interim final rule. After further consideration, the Secretary has also decided to withdraw the October 31, 1991 interim final rule.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities; correction--HCFA. Correction of interim final rule with comment period

This document corrects technical errors that appeared in the interim final rule with comment period published in the Federal Register on May 12, 1998 entitled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities."     

Administrative practices and procedures; internal agency review of decisions--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published in the Federal Register of June 16, 1998 (63 FR 32733), a direct final rule to implement the new Dispute Resolution provision of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on August 31, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medicare program; revisions to payment policies and adjustments to the relative value units under the physician fee schedule, other Part B payment policies, and establishment of the clinical psychologist fee schedule for calendar year 1998; correction--HCFA. Correction of final rule with comment period

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on October 31, 1997 entitled "Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value Units Under the Physician Fee Schedule, Other Part B Payment Policies, and Establishment of the Clinical Psychologist Fee Schedule for Calendar Year 1998.     

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.     

Medicare program; revisions to payment policies and five-year review of and adjustments to the relative value units under the physician fee schedule for calendar year 1997; correction--HCFA. Correction of final rule with comment period

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 22, 1996 entitled "Medicare Program; Revisions to Payment Policies and Five-Year Review of and Adjustments to the Relative Value Units Under the Physician Fee Schedule for Calendar Year 1997."     

Possession, use, and transfer of select agents and toxins. Final rule

This document establishes a final rule regarding possession, use, and transfer of select agents and toxins. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture has established corresponding final rules designed to protect animal and plant health and animal and plant products.     

Medicare program; refinements to geographic adjustment factor values, revisions to payment policies, adjustments to the relative value units (RVUs) under the physician fee schedule for calendar year 1995, and the 5-year refinement of RVUs--HCFA. Correction of final rule with comment period

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 8, 1994 (59 FR 63410) entitled "Medicare Program; Refinements to Geographic Adjustment Factor Values, Revisions to Payment Policies, Adjustments to the Relative Value Units (RVUs) Under the Physician Fee Schedule for Calendar Year 1995, and the 5-Year Refinement of RVUs."