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

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, National Cancer Institute (NCI), the National Institute 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 first California Health Interview Survey (CHIS) Cancer Control Module (CCM) took place in 2001 (2000 CHIS CCM, OMB No. 0925-0478, Federal Register, May 8, 2000, Vol. 65, No. 89, p. 26620). The second survey took place in 2003 (2003 CHIS CCM, OMB No. 0925-0518, Federal Register, October 3, 2002, Volume 67, No. 192, pp. 62067-62068) and the third in 2005 (2005 CHIS CCM, OMB No. 0925-0000, Federal Register, Vol. 69, No. 150, Aug. 5, 2004, pp. 47450-47451, and Federal Register, Vol. 70, No. 1, Jan. 3, 2005, pp. 93-94).

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of July 25, 2006 (71 FR 42096). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the document. The meeting scheduled for September 11, 2006, has been cancelled. There are no other changes.

The Food and Drug Administration (FDA) is amending its nutrition labeling of dietary supplements regulations. This action is being taken to ensure the accuracy of FDA's regulations.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health 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 was previously published in the Federal Register on January 27, 2006 (page 4595) 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 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.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cardiovascular and Renal Drugs Advisory Committee. This meeting was originally announced in the Federal Register of August 1, 2006 (71 FR 43487). The amendment is being made to reflect changes in the Agenda portion of the document. The word ``TRASYOL'' should read ``TRASYLOL''. In the same paragraph, the word ``apportioning'' should read ``aprotinin''. There are no other changes.

This is a Notice of Availability and request for comments on certain draft policy documents prepared by HRSA's Bureau of Primary Health Care (BPHC). HRSA plans to periodically make some draft policy documents (including draft Program Information Notices (PINs)) available for public comment on the Internet at https://bphc.hrsa.gov. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.

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).

The Food and Drug Administration (FDA) is announcing a public hearing on emergency research conducted without informed consent under FDA's emergency research rule. The public hearing announced in this document is part of FDA's Human Subject Protection and Bioresearch Monitoring Initiative. We are particularly interested in hearing the views of individuals and groups who have encountered challenges in the conduct of emergency research in the absence of informed consent, including patient advocacy groups, individuals who have participated in clinical studies, institutional review board members (IRBs), sponsors, clinical investigators, medical societies, ethicists, and other interested parties. We are seeking input on a number of specific questions regarding aspects of emergency research and additional human subject protections. Elsewhere in this issue of the Federal Register, we are also issuing a draft guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.'' We will consider comments received on this draft guidance together with comments and suggestions received at the hearing to determine whether the current framework is adequate for the ethical conduct of emergency research, or whether modifications would be appropriate.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.'' This draft guidance, when finalized, is intended to assist Institutional Review Boards (IRBs), clinical investigators, and sponsors in the development and conduct of emergency research.The draft guidance also describes the additional specific human subject protection requirements for emergency research. Elsewhere in this issue of the Federal Register, FDA is announcing a public hearing on emergency research conducted without informed consent under FDA regulations.

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 license to practice the inventions embodied in PCT (application number pending) filed July 28, 2006 from U.S. provisional application 60/703,814 (E-167-2005/0-US-01), entitled ``System and Methods for Detecting and Characterizing Macromolecular Interactions in Solution'' (Inventors: Drs. Allen Minton and Arun Attri) to Wyatt Technology Corporation (hereafter Wyatt), having a place of business in Goleta, California. The patent rights in these inventions have been assigned to the United States of America.

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 notice informs interested parties of an opportunity to apply for the Frontier Extended Stay Clinic (FESC) demonstration, which is mandated by section 434 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. A FESC is designed to address the needs of seriously or critically ill or injured patients who, due to adverse weather conditions or other reasons, cannot be transferred to acute care hospitals, or patients who do not need a hospital level of care but need monitoring and observation for limited periods of time.

This notice announces a town hall meeting on the Medicare Provider Feedback Group (MPFG). The purpose of the meeting is to solicit the opinions of individual Medicare physicians, providers, and suppliers on selected policies and operational issues that affect providers that participate in the Medicare program. In addition, we will be soliciting input on how we can better serve the Medicare providers and suppliers. All Medicare providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, and other third-party billers, are invited to attend this meeting. We will consider facts and opinions obtained from individual Medicare physicians, providers, and suppliers. We will use the information obtained during the meeting as feedback on selected policy issues and on CMS provider and supplier communication activities and related topics. The meeting is open to the public, but attendance is limited to space available. Registered participants from the meeting may be contacted for follow-up meetings to solicit additional opinions and clarify any issues that may arise from the September 20, 2006 meeting.

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 publication of the criteria FDA intends to use to accredit third parties to conduct inspections of eligible manufacturers of class II or class III medical devices.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR (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/US2004/041256 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 Sahajanand Medical Technologies Pvt. Ltd., registered as a private limited company in accordance with the Companies Act of India, having a principle place of business in Surat, India and U.S. headquarters in Gaithersburg, Maryland. The field of use may be limited to the use of 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the treatment and prevention of stenosis and restenosis and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions. This notice replaces a notice published in 71 FR 46496, August 14, 2006, to correct the heading ``Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions with Nitrite Therapy'' to read ``Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor''.

This notice informs interested parties of an opportunity to apply to participate in a risk reduction/health management demonstration project. This notice also contains information on how to obtain the complete solicitation and supporting information.

This proposed rule would revise 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, and the Deficit Reduction Act (DRA) of 2005. The proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2007. In addition, this proposed rule would revise the current list of procedures that are approved when furnished in a Medicare-approved ambulatory surgical center (ASC), which would be applicable to services furnished on or after January 1, 2007. Further, this proposed rule would revise the ASC facility payment system to implement provisions of the MMA and other applicable statutory requirements, and update the ASC payment rates. Changes to the ASC facility payment system and the payment rates would be applicable to services furnished on or after January 1, 2008. This proposed rule would revise the emergency medical screening requirements for critical access hospitals (CAHs). In addition, this proposed rule would support implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority. This proposed rule would also continue to implement the requirements of the DRA that require that we expand the ``starter set'' of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital Inpatient Prospective Payment System (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. We are proposing to add additional quality measures to the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS[supreg] survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.

This proposed rule would address certain provisions of the Deficit Reduction Act of 2005, as well as make other proposed changes to Medicare Part B payment policy. We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This proposed rule also discusses geographic practice cost indices (GPCI) changes; requests for additions to the list of telehealth services; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; policies related to private contracts and opt-out; policies related to bone mass measurement services, independent diagnostic testing facilities, the physician self-referral prohibition; laboratory billing for the technical component (TC) of physician pathology services; the clinical laboratory fee schedule; certification of advanced practice nurses; health information technology, and the health care information transparency initiative.

Under section 1909 of the Social Security Act (the Act), 42 U.S.C. 1396h, the Inspector General of the Department of Health and Human Services is required to determine, in consultation with the Attorney General, whether a State has in effect a law relating to false or fraudulent claims submitted to a State Medicaid program that meets certain enumerated requirements. If the Inspector General determines that a State law meets these requirements, the State medical assistance percentage, with respect to any amounts recovered under a State action brought under such a law, shall be increased by 10 percentage points. This notice sets forth the Inspector General's guidelines for evaluating whether a State law meets the requirements of section 1909 of the Act.

The purpose of the Community Economic Development (CED) grants is to create new employment and business development opportunities for low-income individuals. The Office of Community Services (OCS) awarded a $663,263 CED grant (Grant No. 90EE0720) to Hall Neighborhood House in Bridgeport, Connecticut, on September 29, 2005. Prior to the expenditure of any of the grant funds, the grantee informed OCS in a letter dated April 17, 2006, that it wished to ``relinquish the management and operation of this program effective immediately.'' The letter stated the grantee's ``current financial instability'' as the reason for the action. In an attempt not to lose the benefits for the community that were intended through the CED grant, OCS identified a possible replacement recipient: Action for Bridgeport Community Development, Inc (ABCD). The organization is being considered as a replacement recipient for the following reasons: ABCD is a previously successful CED grantee (grant 90EE0546). ABCD is headquartered approximately a mile and a half from the offices of Hall Neighborhood House (HNH) in Bridgeport, CT and will serve the same community. Also, ABCD and HNH have worked together in the past and reportedly have maintained a good working relationship. ABCD has a significantly sophisticated budget to manage this project effectively. (In 2003, the organization had gross receipts of approximately $20 million.). ABCD was recently selected by the Head Start Bureau to be the successor grantee of HNH's active Head Start grant. ACF Region I Administrator Hugh Galligan speaks highly of the performance of ABCD and has recommended that it be the replacement recipient. OCS has received and reviewed an application from ABCD. Upon finding that the proposed project is significantly similar to the one chosen for funding through HNH, OCS has requested that ABCD be approved as the permanent replacement recipient for Grant No. 90EE0720.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Marketing Act of 1987'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems, and to implement a number of changes made by the Deficit Reduction Act of 2005 (Pub. L. 109-171). In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These changes are applicable to discharges occurring on or after October 1, 2006. In this final rule, we discuss public comments we received on our proposals to refine the diagnosis-related group (DRG) system under the IPPS to better recognize severity of illness among patientsto use a hospital-specific relative value (HSRV) cost center weighting methodology to adjust DRG relative weights; and to implement consolidated severity-adjusted DRGs or alternative severity adjustment methods. Among the other policy changes that we are making are those changes related to: limited revisions of the reclassification of cases to DRGs; the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; applications for new technologies and medical services add-on payments; payments to hospitals for the direct and indirect costs of graduate medical education; submission of hospital quality data; payments to sole community hospitals and Medicare-dependent, small rural hospitals; and provisions governing emergency services under the Emergency Medical Treatment and Labor Act of 1986 (EMTALA). We are responding to requested public comments on a number of other issues that include performance-based hospital payments for services and health information technology, as well as how to improve health data transparency for consumers. In addition, we are responding to public comments received on a proposed rule issued in the Federal Register on May 17, 2006 that proposed to revise the methodology for calculating the occupational mix adjustment to the wage index for the FY 2007 hospital inpatient prospective payment system by applying an adjustment to 100 percent of the wage index using new 2006 occupational mix survey data collected from hospitals. We are finalizing two policy documents published in the Federal Register relating to the implementation of the Health Care Infrastructure Improvement Program, a hospital loan program for cancer research, established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This final rule also revises the definition of the term ``unit'' to specify the exclusion of units of drugs sold to approved Medicare Competitive Acquisition Program (CAP) vendors for use under the CAP from average sales price (ASP) calculations for a period of up to 3 years, at which time we will reevaluate our policy.

The NTP invites public comments on the proposed review process for the 12th RoC. The proposed review process for the 12th RoC is available on the NTP Web site https://ntp.niehs.nih.gov (select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at the address provided below.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry (183) entitled ``Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions.'' The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Chicago, Illinois'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Chicago, IL. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Chicago, IL, October 23 through 26, 2006, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Monday, October 2, 2006, from 1:30 p.m. to 4 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3d Fl., Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 1:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. Contact Person: Tammie Bell, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0919, e-mail: Tammie.Bell2@fda.hhs.gov, FAX: 301-480-0716. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by September 25, 2006. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance.

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 Blockson Chemical Company (also known as Olin Mathieson), Jolit, Illinois, 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 a revision as warranted by the evaluation, is as follows: Facility: Blockson Chemical Company (also known as Olin Mathieson). Location: Joliet, Illinois. Job Titles and/or Job Duties: All workers who worked in Building 55 at the Blockson Chemical Company. Period of Employment: January 1, 1951 to December 31, 1962.

This notice announces the cancellation of the eighth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.). Canceled Date/Time: August 14, 2006, 1 p.m. to 5 p.m.

Notice is hereby given that the Office of the Assistant Secretary for Administration and Management, Program Support Center, HHS, is proposing to amend its existing System of Records (SOR) entitled, ``PSC Parking Program and PSC Transhare Program Records, No. 09-40-0013.'' This amendment will change the name of the system and incorporate the activities of the PSC security and personal identification verification services into the existing SOR and provide for a more effective application of services. We have provided background information about the amended system in the SUPPLEMENTARY INFORMATION section below.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-sixth meeting, at which, among other things, it will hear presentations on and discuss issues in two broad areas: (1) Organ procurement, allocation, and transplantation and (2) the personal, social, and policy-related significance of genetic information and knowledge. The discussions in both areas are continuations of previous Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the September 2006 meeting) include: human dignity, therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (Working Group) mandated by section 1014 of the Medicare Modernization Act.

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

This notice announces the rescheduled date of the first meeting of the American Health Information Community Confidentiality and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.). The Confidentiality and Security Workgroup was created by the American Health Information Community as a cross-cutting Workgroup comprised of privacy, security, clinical, and technical experts, as well as representation from the consumer perspective. New Date Time: August 21, 2006, 1 p.m. to 4 p.m. This meeting was previously scheduled to be held on August 4, 2006.

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 announcing the availability of a document entitled ``Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease- Associated and Other Immunoglobulin G (IgG) Antibodies,'' dated August 2006. The guidance document is intended to assist Source Plasma manufacturers in submitting to FDA the appropriate information when implementing an IgG antibody collection program or when adding a new IgG antibody collection to an existing program. This guidance finalizes the draft guidance entitled ``Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies,'' dated October 2005, and supersedes the draft reviewers' guide entitled ``Disease Associated Antibody Collection Program,'' dated October 1, 1995.

The Department of Health and Human Services proposes to alter System of Records, 09-25-0168, ``Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.'' NIH proposes a new legal authority for the maintenance of the System to read: 15 U.S.C. 3710, 3710a, 3710c & 3710d and 35 U.S.C. 200 et seq. provide authority to maintain the records; 37 CFR Part 401 ``Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements;'' 37 CFR Part 404 ``Licensing of Government Owned Inventions;'' and 45 CFR Part 7 ``Employee Inventions.'' NIH is also proposing new routine uses for this System. These records will be maintained by the Office of Technology Transfer (OTT), OIR/OD; Office of Financial Management (OFM), OD; Office of Reports and Analysis (ORA), OER/OD; Health and Human Services Technology Development Coordinators and HHS Contract Attorneys who retain files supplemental to the records maintained by the Office of Technology Transfer; and the Extramural Inventions and Technology Resources Branch, OPERA/OER/OD.

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. Proposed Collection: Title: Pretesting of NCI Communication Messages. Type of Information Collection Request: EXTENSION (OMB 0925-0046, expires 10/31/06). Need and Use of Information Collection: In order to carry out NCI's legislative mandate to educate and disseminate information about cancer prevention, detection, diagnosis, and treatment to a wide variety of audiences and organizations (e.g. cancer patients, their families, the general public, health providers, the media, voluntary groups, scientific and medical organizations), it is beneficial for NCI to pretest their communications strategies, concepts, and messages while they are under development. The primary purpose of this pretesting, or formative evaluation, is to ensure that the messages, communication materials, and information services created by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. By utilizing appropriate qualitative and quantitative methodologies, NCI is able to (1) understand characteristics of the intended target audiencetheir attitudes, beliefs, and behaviorsand use this information in the development of effective communication tools and strategies; (2) produce or refine messages that have the greatest potential to influence target audience attitudes and behavior in a positive manner; and (3) expend limited program resource dollars wisely and effectively. Frequency of Response: On occasion. Affected Public: Individuals or households; Businesses or other for profit; Not-for- profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult cancer patients; members of the public; health care professionals; organizational representatives. The annual reporting burden is as follows: Estimated Number of Respondents: 13,780; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .1458; and Estimated Total Annual Burden Hours Requested: 2,010. The annualized cost to respondents is estimated at: $34,155. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

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 expeditions 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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 09/381,497, filed September 20, 1999, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-US-07]; European Patent Application No. 98912977.0, filed October 13, 1999, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-EP-05]; Japanese Patent Application No. 10- 540812, filed March 19, 1998, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059- 1997/0-JP-06]; Australian Patent No. 740904, issued on February 28, 2002, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-AU-03]; and Canadian Patent Application No. 2284665, filed March 19, 1998, entitled ``Recombinant Antibodies and Immunoconjugates Targeted to CD-22 Bearing Cells and Tumors'' [E-059-1997/0-CA-04]; to Cambridge Antibody Technology, Ltd., which has offices in Cambridge, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the BL22 and HA22 and variants thereof as claimed in the licensed patent rights for the treatment of hematologic malignancies.