Department of Health and Human Services October 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed changes to the National Drug Code (NDC) system contained in the agency's proposed rule governing drug establishment registration and drug listing. The proposed rule appeared in the Federal Register of August 29, 2006 (71 FR 51276). In addition, in response to requests for an extension, FDA is extending to January 26, 2007, the comment period for the proposed rule to provide interested parties additional time to submit comments.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information that will permit an applicant to certify that it qualifies as a ``small business'' within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA).

This notice announces the eleventh meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (181) entitled ``Draft Guidance for Industry: Blue Bird Medicated Feed Labels.'' This draft guidance is intended to provide new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's (CVM's) current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act.

This notice announces our proposal to reapprove Medicare Advantage Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for health maintenance organizations and local preferred provider organizations for a term of 6 years. This new term of approval begins July 12, 2006, and ends July 11, 2012. This notice also announces a 30-day period for public comments on renewal of the application.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Annual Reports for Approved Premarket Approval Applications.'' This draft guidance document outlines the information required by a certain FDA regulation in periodic reports (usually referred to as annual reports) and FDA's recommendations for the level of detail that manufacturers should provide. This draft guidance is not final nor is it in effect at this time.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Please be advised that the Hydroxyurea Expert Panel Roster as published in the Federal Register (Vol. 71, No. 199, pp. 60746-60748) on October 16, 2006 should include Francesco Marchetti, Ph.D., Lawrence Berkeley National Laboratory, Berkeley, CA. Marvin Meistrich, Ph.D. was listed as a panel member, but is not a member of the panel.

This notice announces the fifth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems.'' This draft guidance provides FDA's recommendations concerning portable invasive blood glucose monitoring systems (BGMSs).

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for cranial orthosis type devices. These devices are used to improve cranial symmetry in neonates. FDA is publishing this notice in order to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Samples and Protocols'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the Director for the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.

The Translational Research Working Group (TRWG), a broad panel including advocates, researchers from academia, industry representatives, and government officials, was established in early 2005 to evaluate the status of the National Cancer Institute's (NCI) intramural and extramural investment in translational research in order to develop recommendations on ways to coordinate and optimally integrate activities. The TRWG is also charged with developing implementation strategies that will enable the scientific community and NCI leadership to appropriately prioritize its translational research opportunities. Recommendations will be made to the National Cancer Advisory Board in early 2007. To assist in its future planning efforts, the TRWG is asking interested parties for feedback on the seventeen draft initiatives they are proposing. The TRWG compiled these draft initiatives from the comments received during the previous public comment period in early 2006. These draft initiatives address the obstacles to a successful translational research enterprise identified by the TRWG. By listening to interested parties and stakeholders from the wider community, the TRWG hopes to enhance this exciting and important activitycharting the future course of translational progress against cancer.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Sandia National Laboratories Livermore in Livermore, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Sandia National LaboratoriesLivermore in Livermore, California. Locations: Building 913 Room 113, Building 913 Room 128, and Building 941 Room 128. Job Titles and/or Job Duties: All x-ray technologists and materials scientists who worked in the X-ray Diffraction and Fluorescence Laboratory. Period of Employment: December 1967-December 1990.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments,'' dated October 2006. The guidance provides blood and plasma establishments, including licensed blood establishments, unlicensed registered blood establishments, and transfusion services, with the FDA's current thinking related to the biological product deviation reporting requirements. The guidance document will assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The guidance finalizes the draft guidance document under the same title dated August 2001.

This notice announces an administrative hearing to be held on November 22, 2006, at 26 Federal Plaza, Room 38-110a, New York, NY, 10278, to reconsider CMS' decision to disapprove New York State plan amendment 05-49.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV.'' The guidance is intended to encourage sponsors to submit to FDA applications for fixed dose combination (FDC), co-packaged, and single- entity versions of antiretroviral drugs for the treatment of human immunodeficiency virus (HIV). The availability of a wide range of safe and effective antiretroviral products may help facilitate a wider distribution of anti-HIV drugs to better meet the demands of the global HIV/AIDS pandemic.

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ALTACE (ramipril), GEMZAR (gemcitabine), LESCOL (fluvastatin), SANDOSTATIN LAR (octreotide), and SEREVENT (salmeterol). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

This notice announces the eleventh meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the fourth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the eleventh meeting the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Ms. Anne L. Butkovitz from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Ms. Butkovitz was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the act. After being given notice of the proposed permanent debarment and her opportunity to request a hearing within the timeframe prescribed by regulation, Ms. Butkovitz failed to request a hearing. Ms. Butkovitz's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

In January 2006, the Interagency Coordinating Committee on Alternative Methods (ICCVAM) received a test method nomination for the validation of a cell-based estrogen receptor (ER) transcriptional activation (TA) test method from CertiChem, Inc. CertiChem, Inc. submitted a background review document (BRD) containing information on historical development of the test method, the rationale for the test method, and supporting materials. In accordance with the ICCVAM nomination process, NICEATM conducted a pre-screen evaluation of the BRD to determine the extent that it addressed ICCVAM prioritization criteria, submission guidelines, and recommendations for standardization and validation of in vitro endocrine disruptor test methods. NICEATM also reviewed the performance of the test method based on pre-validation data to determine if it warranted consideration for further validation. ICCVAM requests public comments on the pre-screen evaluation titled, ``Pre-Screen Evaluation of the CertiChem, Inc. In Vitro Endocrine Disruptor Assay (Robotic MCF-7 Cell Proliferation Assay of Estrogenic Activity.)'' The pre-screen evaluation is available with supporting documents at (https://iccvam.niehs.nih.gov/methods/ endocrine.htm). ICCVAM also invites public comments on whether this test method should be considered for additional validation studies. In addition, ICCVAM again invites the nomination of other in vitro ER and androgen receptor (AR) binding and TA test methods for which there are standardized test method protocols, pre-validation data, and proposed validation study designs.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Current Beneficiary Survey (MCBS),'' System No. 09-70-6002, last published at 66 Federal Register 15496 (March 19, 2001). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center of the Health Care Financing Administration that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0519. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 4 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain a research database for CMS and other researchers that is capable of producing data sets suitable for both longitudinal and cross-sectional analysis to be used to: (1) Produce projections for current programs and proposed program changes, (2) produce national level estimates of health care expenditures by the aged and disabled, and (3) provide a research database that can be used to provide guidance to program management and policies. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; and (4) support litigation involving the agency. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Competitive Bidding for Clinical Laboratory Services (CBCLS), System No. 09-70- 0589.'' The demonstration project is mandated by section 302(b) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The CBCLS demonstration and evaluation seek to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. Independent, hospital, and physician office laboratories providing non- patient Medicare Part B laboratory services will be required to participate in the demonstration. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who reside in the demonstration area and providers and/or suppliers that are potential participants in the demonstration who provide Medicare Part B clinical laboratory services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Duke University, on behalf of its Duke Clinical Research Institute (DCRI). FDA and Duke University agree to collaborate under the terms and conditions of this MOU, through steering committees and technical working groups, to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goals of identifying indicators of cardiovascular risk, predicting adverse cardiovascular events associated with therapeutic interventions, improving the clinical utility of biomarker technologies as diagnostic and assessment tolls that facilitate the development of safer and more effective cardiovascular therapies, diagnostic, and assessment tools. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium.

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure patient perspectives on the cultural awareness of the healthcare professionals providing care to those patients. This initiative is in response to the need to develop a new CAHPS[supreg] cultural competency survey. AHRQ is interested in incorporating this survey into an integrated set of carefully tested, standardized survey questionnaires and accompanying reports. The addition of the CAHPS[supreg] cultural competency component to the set is intended to empower consumers with quality of care information while also encouraging healthcare professionals to provide culturally competent care. The survey will be designed to assess the quality of care and services provided by healthcare professional in the context of cultural competency. Based on prior work, there are several functional areas that the planned instrument could assess such as: (1) Patient-provider communication (e.g., providers give clear explanations, patients feel that they get all the information they need,), (2) respect for patient preferences/shared decision-making (e.g., providers discuss pros and cons of treatment options, providers understand and takes into account patient's environment, family members are appropriately included in decisions), (3) experiences leading to trust or distrust (e.g., providers treat patients in a culturally sensitive or insensitive manner that led to trust or distrust), (4) experiences of discrimination (e.g., providers or staff treat patients with disrespect because of a patients' racial/ethnic backgrounds, insurance type/ status, lack of proficiency in English), (5) language access (e.g., availability of interpreter services and translated materials), and (6) alternative treatment (e.g., providers are open to discussion about traditional healers and remedies).

The Secretary of Health and Human Services, by authority of 42 U.S.C. 9836A, section 641A(b) of the Head Start Act, as amended (5 U.S.C. Appendix 2), has formed the Advisory Committee on Head Start Accountability and Educational Performance Measures (the Committee). The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2). The function of the Committee is to help assess the progress of HHS in developing and implementing educational measures in the Head Start Program. This includes the Head Start National Reporting System (NRS). The Committee is to provide recommendations for integrating NRS with other ongoing assessments of the effectiveness of the program. The Committee will make recommendations as to how NRS and other assessment data can be included in the broader Head Start measurement efforts found in the Family and Child Experiences Survey (FACES), the National Head Start Impact Study, Head Start's Performance-Based Outcome System, and the ongoing evaluation of the Early Head Start program.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Evaluations of the Medicaid Reform Demonstrations (EMRD),'' System No. 09-70-0068, last published at 67 Federal Register 2216 (January 16, 2002). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09- 70-0523. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractor and/or consultants. The modified routine use will remain as routine use number 1. We propose to combine routine uses 2 and 3 to assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds. As they were duplicative of each other. We will delete routine use number 4, authorizing disclosure to support constituent requests made to a Congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 6 and 7, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We are modifying the language in the routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and provide data necessary to evaluate a series of Medicaid Reform Demonstrations that rely on waivers of section 1115 of the Social Security Act (the Act). This system will allow measurement of the effects of the demonstration on beneficiaries' eligibility, access to care, utilization, health care costs, satisfaction with care, quality of care and health status. The information retrieved from this system of records will also be disclosed to: (1) Support program administration, reporting, and regulator, reimbursement, and policy functions performed within the CMS or by a contractor, consultant, or grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in a Federally-funded health benefits programs. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

An Application Information Meeting, hosted by the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Drug Abuse (NIDA), will be held on October 20, 2006, on the NIEHS campus in Research Triangle Park, North Carolina. The meeting will include an overview of the Exposure Biology Program, presentations on the five funding opportunities, an overview of the cooperative agreement mechanism and Grants Management and Review issues, and a question and answer session addressing RFA-related questions.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is requiring that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. These recordkeeping requirements provide documentation for the provisions in FDA's interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics.'' FDA is requiring recordkeeping because manufacturers and processors of human food and cosmetics need records to ensure that their products do not contain prohibited cattle materials, and records are necessary to help FDA ensure compliance with the requirements of the interim final rule.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2007. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.