Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--ADAMHA. Notice

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11986). Starting this month, a similar notice listing all currently certified laboratories will be published monthly, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory fails to maintain its certification, it will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.     

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--ADAMHA. Notice

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11979, 11986). A similar notice listing all currently certified laboratories will be published during the first week of each month, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory's certification is totally suspended or revoked, the laboratory will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.     

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--HHS. Notice

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11986). A similar notice listing all currently certified laboratories will be published monthly, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory fails to maintain its certification, it will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.     

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies, and laboratories that have withdrawn from the program--SAMHSA. Notice

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of Subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR 29916, 29925). A similar notice listing all currently certified laboratories will be published during the first week of each month, and updated to include laboratories which subsequently apply for and complete the certification process. If any listed laboratory's certification is totally suspended or revoked, the laboratory will be omitted from updated lists until such time as it is restored to full certification under the Guidelines. If any laboratory has withdrawn from the National Laboratory Certification Program during the past month, it will be identified as such at the end of the current list of certified laboratories, and will be omitted from the monthly listing thereafter. This Notice is now available on the internet at the following website: http://www.health.org.     

Current status of accreditation for drug testing in hair

At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.     

Limitation on federal participation for capital expenditures--PHS. Notice of proposed rulemaking

Section 1122 of the Social Security Act, "Limitation on Federal Participation for Capital Expenditures," establishes under which the Secretary may deny Federal reimbursement under titles XVIII and XIX of the Act for expenses related to capital expenditures by or on behalf of health care facilities (1) which the health planning agency designated for a State has found to be inconsistent with standards, criteria, or plans developed under the Public Health Service Act, or (2) for which the designated planning agency was not provided notification as required. These proposed regulations include changes in the regulations now codified at 42 CFR Part 100 based on (1) the proposed amendments to the regulations published in the Federal Register on March 19, 1976, and comments submitted in response to that Notice, (2) the amendments to Title XV of the Public Health Service Act enacted by the Health Planning and Resources Development Amendments of 1979 (Pub. L. 96-79), the Health Programs Extension Act of 1980 (Pub. L. 96-538), and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (3) the amendments to section 1122 enacted by the Health Maintenance Organization Amendments of 1978 (Pub. L. 95-559), the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and the Social Security Amendments of 1983 (Pub. L. 98-21). Interested persons are invited to submit written comments and suggestions concerning this Notice of Proposed Rulemaking (NPRM).     

Foreign patents for the technology transfer from laboratories of U.S. federal agencies

The Journal of Technology Transfer - This paper documents the importance of foreign patents for the technology transfer of inventions created in the laboratories of the U.S. federal agencies....     

FDA Modernization Act of 1997: modifications to the list of recognized standards; availability; withdrawal of draft guidance "Use of IEC 60601 standards; medical electrical equipment"--FDA. Notice

The Food and Drug Administration (FDA) is announcing the publication of the modifications to the list of standards that will be recognized for use in the premarket review process and withdrawing its draft guidance entitled "Use of IEC 60601 Standards; Medical Electrical Equipment." This will assist manufacturers who elect to declare conformity with consensus standards to meet all or part of medical device review requirements.     

Medicare program; legislative changes concerning payment to hospitals for federal fiscal year 1991--HCFA. Notice of legislative changes

This notice describes changes to the Medicare prospective payment system for inpatient hospital services concerning the hospital wage index and the regional payment floor resulting from the provisions of the Continuing Resolution of October 1, 1990 (Pub. L. 101-403). Also described in this notice are those self-implementing portions of sections 4001 (a) and (c), 4002 (e) and (f), 4007, 4151, and 4158 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) that affect Federal fiscal year 1991 payments to prospective payment hospitals and hospitals and units excluded from the prospective payment system. The changes required by these sections affect the following: 15 percent capital payment reduction, use of the regional payment floor, offset for physician assistant services, market basket percentage increase, standardized amounts, hospital-specific rates for sole community hospitals and Medicare-dependent small rural hospitals, target rate of increases for excluded hospitals and units, hospital wage index, payments for graduate medical education, and Part B payment reduction.     

Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.     

Child support enforcement program; state plan requirements, standards for program operations, and federal financial participation--Office of Child Support Enforcement, HHS. Notice of proposed rulemaking

This proposed rule would implement part of the paternity establishment provisions contained in section 331 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) and amended by section 5539 of Pub. L. 105-33, which impose new statutory requirements for a State's voluntary paternity acknowledgement process and require the Secretary to promulgate regulations governing voluntary paternity establishment services and identifying the types of entities other than hospitals and birth record agencies that may be allowed to offer voluntary paternity establishment services. States will be required to adopt laws and procedures that are in accordance with the statutory and regulatory provisions. These proposed regulations will address these procedures and related provisions.     

Medicare program; physician performance standard rates of increase for federal fiscal year 1991--HCFA. Notice

This notice announces the Federal fiscal year (FY) 1991 physician performance standard rates of increase for expenditures and volume of physician services under the Medicare Supplementary Medical Insurance (part B) Program as required by section 1848(f)(2)(C) of the Social Security Act as added by section 4105(d) of the Omnibus Budget Reconciliation Act of 1990. The physician performance standard rates of increase for FY 1991 are the following: 7.3 percent for all physician services, 3.3 percent for surgical services, and 8.6 percent for nonsurgical services.     

Grants for hospital construction and modernization; federal right of recovery and waiver of recovery--PHS. Notice of proposed rulemaking

As a result of recent amendments to sections 609 and 1622 of the Public Health Service Act, the Public Health Service proposes to amend its regulations to provide for (1) written notification to the Secretary when a grant-assisted hospital is sold or no longer used as a health facility eligible for a grant under Title VI or XVI of the Act, (2) waiver of the Government's right of recovery under certain circumstances, and (3) interest on recovery amounts.     

Failure by certain charitable organizations to meet certain qualification requirements; taxes on excess benefit transactions--IRS. Notice of proposed rulemaking

This document contains proposed regulations relating to the excise taxes on excess benefit transactions under section 4958 of the Internal Revenue Code (Code), as well as certain amendments and additions to existing Income Tax Regulations affected by section 4958. Section 4958 was enacted in section 1311 of the Taxpayer Bill of Rights 2. Section 4958 generally is effective for transactions occurring on or after September 14, 1995. Section 4958 imposes excise taxes on transactions that provide excess economic benefits to disqualified persons of public charities and social welfare organizations. The proposed regulations clarify certain definitions and rules contained in section 4958.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the third of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. Additional lists of test systems, assays and examinations by complexity will be published periodically. A complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation list, categorization or recategorization of laboratory test systems, assays and examinations will follow the procedures delineated in 42 CFR 493.17(c). After the effective date of 42 CFR 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992, established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR part 493. This notice announces the fourth of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. After publication and close of comment period on the published partial lists, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, and responses to public comments received on the partial lists will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or re-categorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After the effective date of 42 CFR part 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the second of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. Additional lists of test systems, assays and examinations as well as deletions and corrections will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After September 1, 1992, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published elsewhere in this issue of the Federal Register, establishes criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of the amendments to 42 CFR Part 493 (September 1, 1992). This Notice announces the first of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. Additional lists of test systems, assays and examinations will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise, as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). Notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorize) during the preceding interval.     

International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance.