Medicare program; prospective payment system for hospital outpatient services; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on September 8, 1998, (63 FR 47552). In that rule, as required by sections 4521, 4522, and 4523 of the Balanced Budget Act of 1997, we proposed to eliminate the formula-driven overpayment for certain outpatient hospital services, extend reductions in payment for costs of hospital outpatient services, and establish in regulations a prospective payment system for hospital outpatient services (and for Medicare Part B services furnished to inpatients who have no Part A coverage.) The comment period is extended for 60 days.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered procedures for ambulatory surgical centers effective October 1, 1998; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for the third time on a proposed rule published in the Federal Register on June 12, 1998, (63 FR 32290). In that rule we proposed to make various changes, including changes to the ambulatory surgical center (ASC) payment methodology and the list of Medicare covered procedures. The comment period is extended for 60 days.     

Medical devices; review and revision of compliance policy guides and regulatory requirements for refurbishers, rebuilders, reconditioners, servicers and "as is" remarketers of medical devices; request for comments and information; extension of comment period--FDA. Advance notice of proposed rulemaking; extension of comment period

The Food and Drug Administration (FDA) is extending to June 29, 1998, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of December 23, 1997 (62 FR 67011). This advance notice announced FDA's intention to review and, as needed, to revise compliance policy guides, amend regulatory requirements and, as appropriate, exercise alternative regulatory approaches regarding the remarketing of used medical devices. The agency is taking this action in response to two requests for extensions. This extension of comment period is intended to allow interested persons additional time to submit comments on the ANPRM.     

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

This document extends the comment period for an interim final rule with comment period that was published in the Federal Register on May 12, 1998 (63 FR 26252). That interim final rule implements provisions in section 4432 of the Balanced Budget Act of 1997 related to Medicare payment for skilled nursing facility services. Those include the implementation of a Medicare prospective payment system for skilled nursing facilities, consolidated billing, and a number of related changes. The comment period is extended for 60 days.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered procedures for ambulatory surgical centers effective October 1, 1998; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on June 12, 1998 (63 FR 32290). In that rule we proposed to: Update the criteria for determining which surgical procedures can be appropriately and safely performed in an ambulatory surgical center (ASC): Make additions to and deletions from the current list of Medicare covered ASC procedures based on the revised criteria; Rebase the ASC payment rates using cost, charge, and utilization data collected by a 1994 survey of ASCs; Refine the ratesetting methodology that was implemented by a final notice published on February 8, 1990 in the Federal Register; Require that ASC payment, coverage, and wage index updates be implemented annually on January 1 rather than having these updates occur randomly throughout the year; Reduce requlatory burden; and Make several technical policy changes. This proposed rule implements requirements of section 1833(i) (1) and (2) of the Social Security Act. The comment period is extended for 30 days.     

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; device tracking--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is issuing a final rule to establish a device tracking requirement for certain categories of medical devices as required by the Safe Medical Devices Act of 1990 (the SMDA). In a proposed rule issued on May 27, 1992, and published elsewhere in this issue of the Federal Register, FDA discussed the agency's initial review of certain comments received in response to an earlier proposed rule that published in the Federal Register of March 27, 1992 (57 FR 10702), that has been withdrawn. In issuing this final rule, FDA is providing notice that the proposed rule published elsewhere in this issue of the Federal Register now has the status of a final rule by operation of section 3(c)(2) of the SMDA. FDA is also confirming that the effective date of this rule is March 1, 1993. This rule applies to all devices subject to tracking under the SMDA that are initially introduced into interstate commerce or presented for importation into the United States on or after March 1, 1993. In the proposed rule published elsewhere in this issue of the Federal Register, FDA requests comments on that proposal. Upon closure of the comment period for that proposed rule and consideration of comments responding to both the original March 27, 1992, proposed rule and the new proposed rule, FDA will, if necessary, take further actions to revise the rule.     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.     

Medicare and Medicaid programs; hospital conditions of participation; provider agreements and supplier approval; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This document extends the comment period for a proposed rule that generally would revise the hospital conditions of participation under Medicare and Medicaid, published in the Federal Register (62 FR 66726) on December 19, 1997. The comment period is extended 60 days for all provisions except the proposed new requirements relating to interactions between hospitals and organ procurement organizations, which are extended for an additional 14 days.     

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.     

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.     

Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices--FDA. Final rule; amended economic analysis statement

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.     

Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices--FDA. Final rule; amended economic analysis statement

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.     

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.     

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.     

Human tissue intended for transplantation--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. The regulations are effective upon publication. FDA is taking this action in response to growing concerns that some human tissue products are being offered for transplantation use without even the minimum donor testing and screening needed to protect recipients against human immunodeficiency virus (HIV) infection and hepatitis infection. The new regulations require all facilities engaged in procurement, processing, storage, or distribution of human tissues intended for transplant to ensure that minimum required infectious disease testing has been performed and that records documenting such testing for each tissue are available for inspection by FDA. The regulations also provide authority for the agency to conduct inspections of such facilities and to detain, recall, or destroy tissue for which appropriate documentation is not available.     

Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim final rule to except human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), from the scope of the definition of "human cells, tissues, or cellular or tissue-based products (HCT/P's)" subject to the registration and listing requirements contained in 21 CFR part 1271. That definition became effective on January 21, 2004. FDA is taking this action to assure that these products, which are currently subject to the act and therefore regulated under the current good manufacturing practice regulations set out in the quality system regulations in 21 CFR part 820 are not released from the scope of those regulations before a more comprehensive regulatory framework applicable to HCT/P's, including donor suitability requirements, good tissue practice regulations, and appropriate enforcement provisions, is fully in place. When that comprehensive framework is in place, FDA intends that human dura mater and human heart valves will be subject to it. FDA intends to revoke this interim final rule at that time.     

Medical devices; preemption of state product liability claims--FDA. Withdrawal of proposed rule

The Food and Drug Administration (FDA) is announcing that it is withdrawing a proposed rule that published in the Federal Register of December 12, 1997 (62 FR 65384), relating to medical device preemption of State product liability claims. FDA is making this withdrawal because of concerns that have been raised regarding the interplay between the FDA Modernization Act of 1997 (FDAMA) and the proposed rule.     

Revision to requirements for licensed Anti-Human Globulin and Blood Grouping Reagents. Food and Drug Administration, HHS. Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is amending the regulations to remove the requirements that the products be sterile. FDA is publishing this direct final rule because the requirement that these products be sterile is not necessary for the products to be safe, pure, and potent. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment that warrants terminating the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule.     

Medical devices; medical device reporting; baseline reports. Direct final rule

The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.