Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

The Office of the President's Council on Physical Fitness and Sports (PCPFS) is soliciting proposals for the establishment of partnerships with non-Federal public and private sector organizations, with the goal of developing, implementing, promoting, and evaluating physical activity, fitness, and sports participation activities and initiatives. These partnerships are particularly targeted at calendar year 2006, which marks the 50th anniversary of the PCPFS. This Partnership Initiative is not a grant or contract award program. It is intended to provide opportunities for the Office of the PCPFS and non- Federal public and private sector organizations to work together both to enhance and integrate existing partnerships and also to create new physical activity, fitness, and sports initiatives at the national, state, and local levels to promote better health and fitness for all Americans in a synergistic and collaborative environment. These partnerships will be voluntary, and each partner will be responsible for supporting its own activities. Potential co-sponsors must have a demonstrated interest in physical activity, fitness, and/or sports activities and be willing to participate substantively in the co- sponsored activity.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On July 28, 2005, CDC published a notice in the Federal Register (70 FR 43694) seeking public comments on proposed new vaccine information materials for trivalent influenza vaccines and hepatitis A vaccines. The 60 day comment period ended on September 26, 2005. Following review of the comments submitted and consultation as required under the law, CDC has finalized the influenza vaccine information materials. The final influenza materials, and revised instructions for their use and for use of materials for other covered vaccines, are contained in this notice. The final hepatitis A vaccine information materials will be published later.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the final rule with comment period describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. This final rule with comment period also changes the requirement for physician oversight of mid-level practitioners in critical access hospitals (CAHs). In this final rule with comment period, we also are responding to public comments received on the November 15, 2004, final rule with comment period pertaining to the ambulatory payment classification (APC) group assignment of Healthcare Common Procedure Coding System (HCPCS) codes identified in Addendum B of that rule with the new interim (NI) comment indicator. These changes are applicable to services furnished on or after January 1, 2006.

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, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E- 061-2004/0, ``Mucus Shaving Apparatus for Endotracheal Tubes'' (Patent Application Ser. No. 10/773,570 filed February 5, 2004), and E-061- 2004/1, ``Mucus Shaving Apparatus for Endotracheal Tubes with Bacteriocidal Properties'' (International Patent Application PCT/ US2005/003395 filed February 5, 2005), to C.R. Bard, Inc., a New Jersey corporation having its headquarters in Murray Hill, New Jersey and a division, Bard Medical Division, having offices in Covington, GA. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in the field of cleaning mucus deposits from endotracheal tubes.

The Food and Drug Administration (FDA) is proposing to amend the classification regulations of tinnitus masker devices in order to specify a special control for the device. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that the agency proposes to use as a special control for the device.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 013'' (Recognition List Number: 013), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was published in the August 3, 2005, Federal Register (70 51826) and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted to OMB. PROPOSED COLLECTION: Title: 0917-0028, ``Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children OPM-306''. Type of Information Collection Request: Extention of a currently approved collection which expires November 30, 2005. Type of Information Collection Request: Extension of a currently approved collection which expires November 30, 2005. Form Number: OF- 306 Addendum to Declaration for Federal Employment (OF 306) Indian Health Service Child Care & Indian Child Care Worker Positions. Need and Use of Information Collection: This is a request for approval of collection information required by section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law 101-630, 104 Stat. 4544, 25 U.S.C. 3201-3211. The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. Section 3207(b) of the Indian Child Protection and Family Violence Prevention Act was amended by Section 814 of S. 3031, the Native American Laws Technical Corrections Act of 2000, which requires that the regulations prescribing the minimum standards of character ensure that none of the individuals appointed to positions involving regular contact with, or control over Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution, crimes against persons; or offenses committed against children. In addition, 42 U.S.C. 13041 requires each agency of the Federal government and every facility operated by the Federal government (or operated under contract with the Federal government), that hires (or contracts for hire) individuals involved with children under the age of 18 or child care services to assure that all existing and newly-hired employees undergo a criminal history background check. The background is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal government, or for a facility or program operated by (or through contract with) the Federal government, in positions involved with the provision to children under the age of 18 or child care services, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individual and households. Type of Respondents: Individuals. Table 1 below provides the following: Types of data collection instruments, estimated number of respondents, number of responses per respondent, annual number of responses, average burden hour per response, and total annual burden hour.

The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the name for AOAC INTERNATIONAL. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

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, Office of the Director, 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. Proposed Collection: Title: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414 Exp: 04/06. Need for Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: On occasion. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows:

The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.'' The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II device.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of tetracycline hydrochloride soluble powder in the drinking water of calves, swine, chickens, and turkeys for the treatment and control of various bacterial infections.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Mallinckrodt Chemical Company, Destrehan Street Plant, in Saint Louis, Missouri as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 14, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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 Emergency Shortages Data Collection System (formerly the Emergency Medical Device Shortage Program Survey).

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 proposed information collection project: ``Security Checkpoints and Patients With Radiopharmaceuticals.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

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.

Pursuant to section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will vote on the Annotated Agenda for the WHCoA and may discuss other items related to finalizing the 2005 WHCoA during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This Notice is being published less than 15 days prior to the conference call due to scheduling problems.

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 reporting requirements for filing a notice of participation with FDA.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is included also with this notice. Date and Time: November 14, 2005, 8:30 a.m. to 5 p.m.

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 a guidance for industry entitled ``A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles.'' This guidance is intended to provide information and references that can be used for the decontamination of food transport vehicles following Hurricanes Katrina and Rita in August and September 2005. The scope of this guidance is limited to decontamination of trucks, rail cars, and cold storage units that were flooded or otherwise impacted by the hurricanes, before being placed back in service to transport or store food.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.

In this rule, we finalize provisions specified in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) that establish new data collection, posting, and recordkeeping requirements for skilled nursing facilities (SNFs) and nursing facilities (NFs). It requires that on a daily basis for each shift, SNFs and NFs must post nurse staffing data for the licensed and unlicensed staff directly responsible for resident care in the facility. Facility census information must also be posted. This final rule is also part of a broader communication outreach initiative by CMS to provide beneficiaries, their families, and the public with access to updated data and other information that can assist them in making healthcare decisions.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Council of Healthcare Research and Quality.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), 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. Proposed Collection: Title: The NIDA Primary Care Physician Outreach Project Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a 4-year generic clearance to study the extent to which NIDA is (1) increasing awareness among primary care physicians and other medical professionals about drug addiction as a major public health issue, (2) increasing their awareness of NIDA and NIDA-funded research, and (3) providing them with the information resources needed to incorporate such research findings into their clinical practices. Primary care physicians and other medical professionals, especially those who care for adolescents, are front line individuals helping patients with drug abuse-or drug addiction-related health and mental health problems. Each has key roles in obtaining, disseminating, and applying drug abuse and addiction resource materials in clinical practice. This effort is made according to Executive Order 12862, which directs Federal 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. Formative, process, and outcome evaluations using a multi-method approach (surveys, focus, groups, case studies) will be employed to determine the most appropriate resources and also the usefulness of the materials developed for physicians and other medical professionals. Measures will include the following variables: the information needs and learning styles and preferences of physicians and other medical professionals; their knowledge/awareness of NIDA and the NIDA resources developed for physicians and other medical professionals; their attitudes toward NIDA and the NIDA resources developed for them; their use of the resources developed by NIDA; and ways to strengthen NIDA's knowledge dissemination activities. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals, organizations, and businesses. Type of Respondents: physicians, physician assistants, nurses, medical office managers, hospital/clinic based health educators, and hospital/clinic based social workers. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 1118; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 0.39. Estimated Total Annual Burden Hours Requested: 872.24. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify CFTR gene mutation detection systems into class II (special controls). This guidance document is immediately in effect as the special control for CFTR gene mutation detection 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 the availability of a guidance for industry entitled ``Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modified-release dosage forms of potassium chloride.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 19th set of toxicological profiles, which consists of one new draft and seven updated drafts, prepared by ATSDR for review and comment.

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 use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``2005 Food Safety Survey'' 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 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 information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.

The purpose of this notice is to announce that the National Institutes of Health (NIH) will hold a Town Hall meeting to hear comments and insights concerning possible revisions to certain fiscal policies that govern the Ruth L. Kirschstein National Research Service Awards (NRSA), which comprise institutional training grants (T32 and T34s) and individual fellowships (F30, F31, F32, F33). The meeting which is open to the public will focus primarily on the funding of educational costs such as tuition, fees and health insurance provided through institutional training grants. The meeting will be held November 30, 2005 in the Natcher Conference Center, Room E1/E2 on the NIH campus in Bethesda, Maryland. Background: NRSA programs currently support over 17,000 predoctoral and postdoctoral research training positions mostly in the nation's academic laboratories. While the budget for the NRSA programs grew smartly during the five years in which the overall appropriation for the NIH was doubled, since fiscal 2003, the last of the growth years, the appropriation for NRSA training programs has grown rather modestly. Given this reality, the NIH must re-examine aspects of its NRSA policies that may not be sustainable in a period of limited budget expansion. The largest of the NRSA programs funds institutional training grants that use the T32 mechanism to support both pre- and post- doctoral research training. Currently, the direct cost funding of these programs is segmented into four categories: stipend, tuition/fees/ health insurance (referred to collectively as tuition), travel, and training related expenses. The funding levels for three of these (stipend, travel, and training related expenses) are stipulated and controlled by NIH, although each can be adjusted as fiscal circumstances and program needs evolve. The funding for tuition, on the other hand, is not fully controlled by NIH; the funding for tuition is governed by a formula tied to the amount each institution requests for this expense. The formula provides for each T32 trainee the sum of $3,000 plus sixty percent of the requested tuition in excess of $3,000. This formula is used to determine the tuition level provided via each competing grant; that level, once established for a given competing grant, is used for the subsequent non-competing renewal awards during the project period. This formula has been employed since fiscal 1996 and has been modified once. During the five year growth period, the increased funding devoted to NRSA activities was used for meaningful, and long overdue, trainee stipend increases and for covering some of the escalating requests in the tuition category of training grants. However, in fiscal 2004 and 2005, when there was limited NRSA budget growth, the requests and outlays for tuition continued to rise substantially. Barring other adjustments, the continuation of this trend in tuition growth will result in a significant annual decrease in the number of NRSA trainee positions, and to fewer programs supported by T32 training grants. Since these outcomes could have a substantial disruptive effect on biomedical research training, NIH has frozen the tuition expenses on competing renewals of T32 awards in fiscal 2006. (See https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html) Moreover, NIH training officials have decided to study various options for handling the funding of trainee tuition in the future. The goal of this effort is to find an approach that equips the agency both to adjust to budgetary challenges and to continue to provide appropriate support to institutions to help defray the educational costs of NRSA trainees. This town hall meeting is being held to gather the views of the training community on this issue. Among the options that will be studied are the following: 1. The current tuition formula could be applied in conjunction with a ceiling; the funds provided would be the amount dictated by the currently-used formula or the amount dictated by the ceiling, whichever is less. The magnitude of the ceiling would be based on the fiscal resources available as well as on applicable data. For the sake of discussion, those offering comments may assume the ceiling could be in the range of $16,000 to $18,000. 2. A fixed allowance could be provided for tuition; the same allowance per trainee would be provided to each grantee institution. This approach is employed by the National Science Foundation for its graduate research fellowship program. For the sake of discussion, those offering comments may assume the allowance could be in the range of $16,000 to $18,000. The allowance could be adjusted periodically by the NIH as fiscal circumstances warranted. 3. The current tuition formula could be retained without modification. Those offering comments may assume that under this option the number of NRSA trainees and funded training grant programs will likely experience a series of year-to-year decreases as long as the current fiscal patterns prevail. Participation: Those who wish to attend the Town Hall meeting are invited to submit a brief statement, not to exceed two pages, summarizing views and experiences relevant to the topic of the meeting. Some of those submitting statements will be asked to make brief oral presentations at the meeting. In selecting those to make presentations and in allocating time, the organizers hope to ensure that a full range of opinions is heard and that all parts of the NRSA constituency are represented. Those not asked to present will be welcome at the meeting and will be given a brief opportunity to contribute during two ``open mike'' sessions. Individuals should submit their statements along with their name, affiliation, and contact information to NRSATownHall@mail.nih.gov by November 4, 2005. Individuals chosen to make presentations at the Town Hall meeting will be notified on or around November 14, 2005. Those unable to attend but who wish to provide statements are welcome to do so. All statements will be considered by NIH staff. Those who do not submit statements but wish to observe the meeting will be admitted on a space-available basis. An NIH official will present background information on NRSA tuition support at the outset of the meeting. All individuals who wish to attend the meeting should register through the Town Hall meeting's Web site at https://pub.nigms.nih.gov/ nrsameeting, available on or about October 24, 2005. The detailed schedule for the meeting, when completed, will be posted on this Web site along with any meeting updates. Participants are responsible for their own expenses associated with participating in this meeting, such as for travel. Inquiries: Questions concerning this notice should be directed to: Dr. Warren Jones, National Institute of General Medical Sciences, National Institutes of Health, 301-594-3827, jonesw@nigms.nih.gov.

The NTP has developed and refined a vision for toxicology in the 21st century (``NTP Vision'') and a roadmap for implementing its vision (``NTP Roadmap'') to strategically place the program at the forefront of providing scientific data and its interpretation for use in public health decision-making (see NTP Web site https:// ntp.niehs.nih.gov select ``NTP Vision and Roadmap''). As part of the NTP Roadmap, the NTP will convene a series of workshops, including the High Throughput Screening Assays Workshop, to discuss test methods and approaches that will enhance the program's ability to efficiently evaluate the large number of substances in our environment for which there is little or no information about their potential hazard for human health. This workshop is scheduled for December 14-15, 2005, at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA and will focus on providing information about high throughput screening techniques and the potential utility of this technology for toxicology and the NTP. This meeting is open to the public and attendance is limited only by the space available. Individuals may register to attend the workshop on a first-come, first- served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials and participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

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.