Revision of the requirements for live vaccine processing; confirmation of effective date. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) is confirming the effective date of March 18, 2008, for the direct final rule that appeared in the Federal Register of October 18, 2007 (72 FR 59000). The direct final rule amends the biologics regulations by providing options to the existing requirements for the processing of live vaccines. This document confirms the effective date of the direct final rule.     

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.     

Revisions to the requirements applicable to blood, blood components and source plasma; confirmation of effective date and technical amendment. Direct final rule; confirmation of effective date and technical amendment

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.     

Conforming regulations regarding removal of section 507 of the Federal Food, Drug, and Cosmetic Act; confirmation of effective date. Food and Drug Administration, HHS. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) published in the Federal Register of January 5, 1999 (64 FR 396), a direct final rule. The direct final rule amended FDA's regulations by removing references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. The direct final rule also removed references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. This document confirms the effective date of the direct final rule.     

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.     

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.     

Medicare and Medicaid programs; salary equivalency guidelines for physical therapy, respiratory therapy, speech language pathology, and occupational therapy services; revised effective date and technical correction--HCFA. Final rule; delay of effective date and correction

This document delays the effective date of the final rule on salary equivalency guidelines, published in the Federal Register (63 FR 5106) on January 30, 1998, from April 1, 1998 to April 10, 1998. In addition, we are making a technical correction in the preamble to the January 30, 1998 final rule.     

Medical devices; device tracking--FDA. Final rule; suspension of effective date; notification of status under the Safe Medical Devices Act; technical amendments

The Food and Drug Administration (FDA) is announcing that it is suspending the effective date of the final rule on device tracking that appeared in the Federal Register of May 29, 1992, until August 29, 1993. The agency is also announcing that the revised proposed rule is now a final rule by operation of law. Further, the agency is amending the regulations to make certain technical amendments. This action is being taken to implement requirements of the Safe Medical Devices Act of 1990 (the SMDA) and the Medical Device Amendments of 1992 (the 1992 amendments).     

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.     

Protection of human subjects; prisoners used as subjects in research; stay of effective date--Food and Drug Administration. Final rule; stay of effective date

The Food and Drug Administration (FDA) is staying the effective date of its regulations establishing conditions under which biomedical research o prisoners will be accepted in satisfaction of FDA's regulatory requirements. All provisions of Subpart C of Part 50 of the final regulations are stayed pending reproposal of the subpart, including 50.44 (21 CFR 50.44). The stay will remain in effect until final action taken on the reproposal in effective.     

Medicare program; electronic submission of cost reports: revision to effective date of cost reporting period. Interim final rule with comment period

This interim final rule with comment period revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This interim final rule with comment does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.     

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.     

Medicare program; prospective payment system for long-term care hospitals RY 2009: annual payment rate updates, policy changes, and clarifications; and electronic submission of cost reports: revision to effective date of cost reporting period. Final rule

This final rule updates the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). We are also consolidating the annual July 1 update for payment rates and the October 1 update for Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) weights to a single rulemaking cycle that coincides with the Federal fiscal year (FFY). In addition, we are clarifying various policy issues. This final rule also finalizes the provisions from the Electronic Submission of Cost Reports: Revision to Effective Date of Cost Reporting Period interim final rule with comment period that was published in the May 27, 2005 Federal Register which revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This final rule does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule that appeared in the Federal Register of May 14, 1999 (64 FR 26282). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is hereby amending Title 21 Code of Federal Regulations to reinstate the former provisions. In addition, FDA is correcting the precision of the value for protein concentration that was inadvertently omitted from the codified section of the direct final rule.     

Extension of the expiration date for several body system listings. Final rule

We use the Listing of Impairments (the listings) at the third step of the sequential evaluation process when we evaluate your claim for benefits based on disability under title II and title XVI of the Social Security Act (the Act). This final rule extends until July 3, 2006, the date on which listings for four body systems will no longer be effective and extends until July 2, 2007, the date on which the listings for eight body systems will no longer be effective. Other than extending the date during which the listings will be effective, we have made no revisions to the listings; they remain the same as they now appear in the Code of Federal Regulations. This extension will ensure that we continue to have the medical evaluation criteria in the listings to adjudicate disability claims in these body systems at step three of the sequential evaluation process.     

Revisions to the requirements applicable to blood, blood components, and source plasma; confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule issued in the Federal Register of August 19, 1999. The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is amending Title 21 Code of Federal Regulations to reinstate the former provisions.