Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Role of HIV Resistance Testing in Antiretroviral Drug Development.'' This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the agency's current thinking regarding the role of HIV resistance testing during antiretroviral drug development and postmarketing. This guidance discusses important nonclinical studies that are recommended before the initiation of phase 1 clinical studies in HIV-infected patients. In addition, this guidance addresses the use of resistance testing in clinical phases of drug development and recommends the type of information that should be collected and the types of analyses that should be conducted to characterize an antiretroviral's resistance profile. This guidance finalizes the draft guidance published on November 29, 2004.

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The draft guidance announced in this notice supersedes FDA's ``Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees,'' dated January 2002.

The Health Resources and Services Administration published a notice in the Federal Register of October 5, 2007 (FR Doc. E7-19747), on pages 57049-57052, regarding response to solicitation of comments and publication of final program eligibility guidelines.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing a notice of a proposal to add a new system of records. The Campus Based Branch (CBB) of the Division of Health Careers Diversity and Development in the Bureau of Health Professions is currently utilizing a document management system (DMS) that dynamically manages its flow of documents produced and received. the DMS is an intra-office system in which documents contained within the system are only shared among CBB staff. The DMS contains names and other personally identifiable information of borrowers.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications'' dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005.

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 Combustion Engineering, Windsor, Connecticut, 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: Combustion Engineering. Location: Windsor, Connecticut. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1965 through December 31, 1972.

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 Horizons, Inc., Cleveland, Ohio, 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: Horizons, Inc. Location: Cleveland, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1944 through December 31, 1956; and January 1, 1957 through July 31, 2006 (residual period).

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 the Westinghouse Atomic Power Development Plant, East Pittsburgh, Pennsylvania, 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: Westinghouse Atomic Power Development Plant. Location: East Pittsburgh, Pennsylvania. Job Titles and/or Job Duties: All testers and laboratory researchers (to include research group leaders who worked in the L Building (and K Building as applicable). Period of Employment: January 1, 1942 through December 31, 1944.

On March 30, 2007, we published a final rule entitled ``Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants.'' The effective date was June 28, 2007. This correcting amendment corrects a technical error identified in the March 30, 2007 final rule.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on August 21, 2007, pages 46640-46641, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Collection Request: Renewal (OMB No. 0925-0493). Need and Use of Information Collection: This project identifies and quantifies factors associated with the presence and progression of subclinical cardiovascular disease (CVD)that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 550; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: .2; and Estimated Total Annual Burden Hours Requested: 36.7. The annualized cost to respondents is estimated at $5,595, assuming respondents time at the rate of $18.65 per hour and physician time at the rate of $75 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing that it intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after April 28, 2008. FDA intends to exercise its enforcement discretion with respect to unapproved pancreatic enzyme drug products until April 28, 2010, if the manufacturers have investigational new drug applications (INDs) on active status on or before April 28, 2008, and have submitted new drug applications (NDAs) on or before April 28, 2009. FDA is granting this extension to ensure the availability of exocrine pancreatic insufficiency drug products during the additional time needed by manufacturers to obtain marketing approval.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting on updating the NIOSH publication ``Occupational Exposure Sampling Strategies Manual''. The document can be found at https://www.cdc.gov/niosh/docs/77-173/. Instructions are provided for submitting comments. Public Meeting Dates and Times: November 8, 2007, 8:30 a.m. to 4:30 p.m. EST and November 9, 2007, 8:30 a.m. to 12 p.m. EST. Place: Washington Court Hotel, 525 New Jersey Avenue, NW., Washington, DC 20001. Purpose of Meeting: To obtain input from stakeholders on their needs for information and guidance to be included in a revision of the ``Occupational Exposure Sampling Strategies Manual'' (OESSM), which is sometimes referred to as ``Leidel, Busch and Lynch'' or ``The NIOSH Yellow Book'' [https://www.cdc.gov/niosh/77-173.html]. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Persons wanting to attend and contribute comments at the meeting are requested to register at https://www.team-psa.com/niosh-OESSM07/home.asp no later than November 1, 2007. Unreserved walk-in attendees will be accommodated on the day of the meeting if space is available. The meeting has several scheduled presentations and panels that will include time for questions and answers. In addition, two breakout sessions will be held to solicit discussion and input on specific occupational exposure issues. Presentations, questions, and oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C- 34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091 and must be submitted by November 30, 2007 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-091. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the current practice, limitations, and needs for development of occupational exposure assessment practices and policies. NIOSH will use this information to assess the needs and scientific basis for revisions to its guidance and recommendations in occupational exposure assessment. Contact Person for Technical Information: Paul Middendorf, telephone (513)533-8606, M/S C-9, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Contact Person for Submitting Comments/Meeting Attendance: Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

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 Food and Drug Administration (FDA) is announcing the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this document were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) from Schering-Plough Animal Health Corp. to Huvepharma AD.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five approved new animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (``Lookback'')'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the list of proposed substances that will be evaluated for CERCLA Set 22 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.

The Food and Drug Administration (FDA) is issuing this notice to explain the new direct-to-consumer (DTC) user fee program (DTC user fee program) established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and, as required by the new law, to ask companies to notify FDA within 30 calendar days if they intend to participate in the DTC user fee program during fiscal year (FY) 2008 and, if they do plan to participate, to identify the number of DTC television advertisements for prescription drug and biological products they plan to submit for advisory review during FY 2008. The information gathered in response to this notice will be used to establish the FY 2008 fee that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The proposed information collection was previously published in the Federal Register on July 25, 2007, in Volume 72, No. 142, pages 40887-40888, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NICHD Research Partner Satisfaction Surveys. Type of Information Collection Request: Extension without change. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NICHD seeks to obtain OMB's generic approval to conduct customer satisfaction surveys surrounding its research programs and activities. The NICHD was founded in 1963. Its mission is to ensure, through research, the birth of healthy infants and the opportunity for each to reach full potential in adulthood, unimpaired by physical or mental disabilities. The NICHD conducts and supports research on the many factors that protect and enhance the process of human growth and development. The developmental focus of the NICHD means that its research portfolio is unusually broad. NICHD programs include research on infant mortality, birth defects, learning disorders, developmental disabilities, vaccine development, and demographic and behavioral sciences, among others. In addition to supporting basic research, clinical trials, and epidemiological studies that explore health processes, the NICHD forms partnerships with organizations or institutions to ensure effective use of scientific findings and research products. The NICHD utilizes strategic assessments to support Institute planning and policy development, and to help determine programmatic and scientific objectives and priorities. Research partner surveys will augment NICHD's ongoing efforts to assess research-related activities. The two principal objectives are: (1) To measure the personal satisfaction of research partners with NICHD programs or initiatives, including both responsiveness to scientific aims and convenience of operations to support research and its effective use; and (2) to learn from research partners the ways in which the NICHD can improve the overall planning and management of it programs and initiatives. Findings will be used to improve NICHD's research programs and initiatives in the following ways: (1) To assess the effectiveness and efficiency of operations; (2) to identify opportunities for improving program performance; (3) to develop plans to incorporate innovations in program management; (4) to measure partner satisfaction and document program outcomes for governmental accountability reporting; and (5) to identify the need for creating new programs or initiatives or restructuring existing ones to respond to emerging scientific opportunities. Frequency of Response: Annual [As needed on an ongoing and concurrent basis]. Affected Public: Members of the public, researchers, practitioners, and other health professionals. Type of Respondents: Members of the public; eligible grant applicants and actual applicants (both successful and unsuccessful); clinicians and other health professionals; and actual or potential clinical trials participants. The annual reporting burden is as follows: Estimated Number of Respondents: 28,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: Varies with survey type, see below; and Estimated Total Annual Burden Hours Requested: 5,883. The annualized cost to respondents is estimated at: $109,541.46. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing a public hearing concerning FDA's policies regarding salt (sodium chloride) and sodium in food. FDA also is announcing the availability for comment of a citizen petition, submitted by the Center for Science in the Public Interest (CSPI), requesting that FDA make changes to the regulatory status of salt, require limits on salt in processed foods, and require health messages related to salt and sodium. The purpose of the hearing is for FDA to share its current framework of policies regarding salt and sodium and to solicit information and comments from interested persons on this current framework and on potential future approaches, including approaches described in the citizen petition.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Advertisements for Prescription Drugs'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 the availability of the guidance entitled ``Class II Special Controls Guidance Document: Remote Medication Management System.'' This guidance document describes a means by which remote medication management systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify remote medication management systems into class II (special controls). This guidance document is being immediately implemented as the special control for remote medication management systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 15, 2007 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is proposing to amend the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for processing live vaccines is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is amending its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The changes apply to drug products that are life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product. The final rule implements provisions of the Modernization Act by requiring an applicant who is the sole manufacturer of one of these products to notify FDA at least 6 months before discontinuing manufacture of the drug product.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license worldwide to practice the invention embodied in United States issued Patent Number 7,052,907 titled: ``Adult Human Dental Pulp Stem Cells in vitro and in vivo'' referenced at HHS as E-233-2000/0-US-03 and corresponding foreign patent applications, United States Patent Application Number 10/553,633 titled: ``Postnatal Stem Cells and Uses Thereof'' referenced at HHS as E-018-2003/0-US-02 and corresponding foreign patent applications, United States Patent Application Number 11/433,627 titled: ``Multipotent Postnatal Stem Cells from Human Periodontal Ligament'' referenced at DHHS as E-033-2004/0-US-03 and corresponding patent applications, to Angioblast Systems, Inc. having a place of business in the state of New York. The field of use may be limited to the following: FDA or similar foreign body approved therapeutic for (1) regeneration/repair of the periodontal ligament lost from chronic periodontitis, (2) regeneration/repair of dentin/pulp complex lost during deep carious lesions and (3) regeneration/repair of neural networks. The United States of America is the assignee of the patent rights in this invention. The territory may be worldwide.

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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in PCT patent application PCT/US2004/041265 filed December 9, 2004, entitled: ``Methods for Suppressing an Immune Response or Treating a Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], to Emiliem, Inc., a Delaware Corporation, having a place of business in Emeryville, California. The field of use may be limited to the use of 2-(4-piperazinyl) substituted 4H-1-benzopyran-4-one compounds, including 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the treatment of cancer and/or other proliferative disorders not currently licensed, excluding the treatment and prevention of stenosis and restenosis. The United States of America is an assignee of the patent rights in these inventions.

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.

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Physical Fitness and Sports will hold a meeting. This meeting is open to the public. A description of the Council's functions is included also with this notice.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

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 the availability of a draft guidance entitled ``Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist the dietary supplement industry in complying with the serious adverse events reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Separate guidance, issued by the Center for Drug Evaluation and Research on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.

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:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2007 (72 FR 56771). The document announced the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The document was published with an incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2008. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2008 fee rates are provided in this notice. These fees apply from October 1, 2007, through September 30, 2008. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This notice provides information on how the fees for FY 2008 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Quality System Regulation Educational Forum on Design Controls.'' This public workshop is intended to provide information about FDA's Medical Device Quality Systems Regulation (QSR) to the regulated industry, particularly small businesses. Date and Time: The public workshop will be held on April 4, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Omni Mandalay Hotel at Las Colinas, 221 East Las Colinas Blvd., Dallas (Irving), TX 75039. Directions to the facility are available at the FMDIC Web site at https://www.fmdic.org/. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail david.arvelo@fda.hhs.gov. Registration: FMDIC has a $250 early registration fee. Early registration ends March 21, 2008. Registration is $350 thereafter. To register online, please visit https://www.fmdic.org/. As an alternative, you may send registration information including name, title, firm name, address, telephone and fax numbers, and e-mail, along with a check or money order for the appropriate amount payable to the FMDIC, to Dr. William Hyman, Texas A&M University, Department of Biomedical Engineering, 3120 TAMU, College Station, TX 75843-3120. Registration onsite will be accepted on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to the FMDIC. The registration fee will be used to offset expenses of hosting the event, including meals, refreshments, meeting rooms, and materials. If you need special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 21 days in advance. Transcripts: Transcripts of this event will not be available due to the format of this workshop. Event handouts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

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.