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

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and is available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710a, to achieve expeditious commercialization of results of federally funded research and development. A provisional patent application has been filed. In addition, the invention is protected by copyright registration. A Patent Cooperation Treaty (PCT) application and national stage foreign patent applications claiming priority to the Patent Cooperation Treaty (PCT) application are expected to be filed within the appropriate deadlines to extend market coverage for U.S. companies and may also be available for licensing.

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

The Food and Drug Administration (FDA), Baltimore District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, May 17, 2006, from 8:30 a.m. to 5 p.m. and Thursday, May 18, 2006, from 8:30 a.m. to 4 p.m. Location: The public workshop will be held at the Radisson Plaza Lord Baltimore, 20 West Baltimore St., Baltimore, MD 21201, 410-539- 8400, FAX: 410-625-1060. Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215- 717-3703, FAX: 215-597-5798, e-mail: Marie.Falcone@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $550 (member), $625 (nonmember), or $500 (Government employee nonmember). (The registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To register via the Internet go to https://www.socra.org/FDA Conference.htm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-822-8644, or e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Radisson Plaza Lord Baltimore hotel at the reduced conference rate, contact the Radisson Plaza Lord Baltimore hotel (see Location) before April 17, 2006. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone (see Contact) at least 7 days in advance of the workshop.

This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including Territories and Insular Areas). The purpose of these grants is to assist States in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2006.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Beneficiary Database (MBD),'' System No. 09-70-0536. This system was last published at 66 FR 63392 (December 6, 2001). The initial stage of development of the MBD contained data of interest to the Medicare Managed Care program. Since publication of the notice in 2001, all proposed phases of development for this system have been completed. We propose to broaden the scope of this system to collect and maintain data elements necessary for the new voluntary prescription drug benefit program required by Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). This new prescription drug benefit program was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The regulations establishing the new Medicare ``Part D'' Prescription Drug Benefit program are codified at Title 42 of the Code of Federal Regulations (CFR), Parts 403, 411, 417 and 423. Although the database has always contained the entire Medicare beneficiary population, the broadened scope of this modification will document the completion of the following phases: Phase II completed the development of data elements of interest to the Medicare Fee-For- Service Program; Phase III incorporated data elements necessary to implement the Medicare prescription drug discount card program; and Phase IV will complete the development of the MBD to include all provisions mandated by the MMA. To more accurately reflect the information maintained in this system we will change any reference to the program under Part C of Title XVIII currently referred to as the ``Medicare+Choice Program'' to read the ``Medicare Advantage (MA) Program.'' The MA Program shall consist of the program under Part C of Title XVIII of the Act, to include MA and MA-PD. Information maintained in this system related to the MA and MA-PD shall be derived from the Medicare Advantage Prescription Drug System (MARx) (formerly known as the ``Medicare Managed Care System (MMCS)) System No. 09-70-4001. Generally, coverage for the prescription drug benefit under Part D will be provided under PDPs, which will offer only prescription drug coverage. Under Part C, Medicare Managed Care Organizations will offer prescription drug coverage that is integrated with the health care coverage they provide to beneficiaries and will be referred to as Part C of the Medicare Program. The broadened scope of the Part D benefit will include the following activities; (1) determination of the status of Medicare beneficiaries who are eligible for the Low Income Subsidy Program (LIS) and are deemed to receive certain drug benefits; and (2) auto- assignment/auto-enrollment of beneficiaries as required by the MMA, to include all LIS and deemed individuals who are not voluntarily enrolled in a drug plan, will automatically be assigned to a Prescription Drug Plan (PDP) or Medicare Advantage (MA) Prescription Drug Plan (MA-PD). Information will be received from state organizations and from the Social Security Administration (SSA) and the MBD will make the final determination as to the status of the beneficiary. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include grantees who perform a task for the agency. The modified routine use will remain as routine use number 1. We will also modify existing routine use number 5 to change the name from Peer Review Organizations to read Quality Improvement Organizations (QIO) and to reflect requirements established for QIOs related to the Medicare Part D Program. The modified routine use will remain as routine use number 5. We further propose to modify published routine use number 6 that permits disclosure to other insurers. We will expand the stated requirements related to coordination of benefits for the Medicare program, to implement the Medicare Secondary Payer (MSP) provisions, and to clarify CMS'' policy on disclosure of privacy protected data elements maintained in this system. The modified routine use will remain as routine use number 6. We will modify the language in the remaining routine uses to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their proposed usage. We will also take the opportunity to update any sections of the system that were affected by recent reorganizations and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to provide CMS with a singular, authoritative, database of comprehensive data on individuals in the Medicare program to support ongoing and expanded program administration, service delivery modalities, and payment coverage options. This collection will contain a complete ``beneficiary insurance profile'' that reflects the individual Medicare and Medicaid health insurance coverage and Medicare health plan and demonstration enrollment. This system will also included data necessary to process certain activities associated with the new Medicare prescription drug benefit program. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) support providers and suppliers of services for administration of Title XVIII; (4) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (5) support Quality Improvement Organizations (QIO); (6) assist other insurers for processing individual insurance claims; (7) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (8) support constituent requests made to a congressional representative; (9) support litigation involving the agency; and (10) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

In accordance with the requirements of the Privacy Act, the HHS DAB is publishing a notice of a system of records entitled, ``Medicare Appeals Council Records, HHS/OS/DAB No. 09-90-0048.'' We have provided background information about the proposed system in the SUPPLEMENTARY INFORMATION section below.

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 (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/337,179 filed December 4, 2001, entitled ``IL-13 Receptor-Targeted Immunotoxins Ameliorates Symptoms of Asthma and of Allergy'' [HHS Reference No. E-296-2001/0-US- 01], PCT Application No. PCT/US02/00616 filed February 28, 2002, entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-PCT-02], U.S. Patent Application No. 10/497,804 filed June 4, 2004, entitled ``Alleviating Symptoms of TH2- Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-US- 03], Australian Patent Application No. 2002258011 filed June 8, 2004, entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-AU-04], Canadian Patent Application No. 2469082 filed February 28, 2002, entitled ``Chimeric Molecule for the Treatment of TH2-Like Cytokine Mediated Disorders'' [HHS Reference No. E-296-2001/0-CA-05], and European Patent Application No. 02727815.9 filed June 29, 2004 entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-EP-06], including background patent rights to U.S. Patent No. 4,892,827, issued on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxins: Construction of an Active Immunotoxin with Low Side Effects'' [HHS Reference No. E-385-1986/0-US-01], U.S. Patent No. 5,919,456, issued on July 6, 1999, entitled ``IL-13 Receptor Specific Chimeric Proteins'' [HHS Reference No. E-266-1994/0-US-07], U.S. Patent 6,518,061, issued on February 11, 2003, entitled ``IL-13 Receptor Specific Chimeric Proteins and Uses Thereof'' [HHS Reference No. E-266-1994/0-US-08], to NeoPharm, Inc., which has offices in Waukegan, Illinois. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of asthma and pulmonary fibrosis with IL13-PE38.

The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's report on the status of the studies sponsors have agreed to or are required to conduct.