Department of Health and Human Services May 2007 – 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.

This notice, in accordance with 35 U.S.C. Sec. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in PCT Application No. PCT/US01/04125, filed February 9, 2001, entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-PCT-02]; U.S. Patent No. 7,148,061, issued December 12, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-US-03]; U.S. Patent Application No. 11/637,272, filed December 12, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E- 095-2000/0-US-08]; PCT Application No. PCT/US06/24909, filed June 26, 2006, entitled ``A Potential Novel Therapeutic Protein Molecule of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptor Type 1'' [E-095-2000/4-PCT-01]; European Patent Application No. 01910476.9, filed February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-EP-06]; Australian Patent Application No. 2001238076, filed on February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-AU-04]; Australian Patent Application No. 2006203490, filed on August 11, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-AU-07]; and Canadian Patent Application No. 2399388, filed February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-CA-05] to Welson Pharmaceuticals, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for rheumatoid arthritis (RA) using Welson's proprietary platform.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for the opportunity for pubic comment on the proposed data collection projects, the Warren Grant Magnuson Clinical Center (CC), 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: Customer and Other Partners Satisfaction Surveys. Type of Information Collection Request: New request/waiver. Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; and (4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center's operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer's needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households; businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center's major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: Clinical Center patients, family members of Clinical Center patients, visitors to the Clinical Center, National Institutes of Health investigators, NIH intramural collaborators, private physicians or organizations who refer patients to the Clinical Center, volunteers, vendors and collaborating commercial enterprises, small businesses, regulators, and other organizations. The annual reporting burden is as follows:

The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to a Stakeholder Dialogue. Attendees will meet the NCCAM Acting Director and discuss the Center's activities and priorities. The Dialogue will take place on June 20, 2007 in Bethesda, Maryland. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. To date, NCCAM's efforts to rigorously study CAM, to train CAM researchers, to conduct outreach, and to facilitate integration have been guided by NCCAM's strategic plans located on the NCCAM Web site at https://nccam.nih.gov/about/plans/fiveyear/index.htm. Request for Participation: The public is invited to provide input into the NCCAM's priorities and activities at a Stakeholder Dialogue. This event will give NCCAM stakeholders an opportunity to voice their opinions regarding future directions for research, training, outreach, and integration in complementary and alternative medicine (CAM). The Dialogue will be held: June 20, 2007, 9 a.m. to 3 p.m., Natcher Conference Center, National Institutes of Health,Bethesda, Maryland 20892. NCCAM's acting director will provide an overview of NCCAM's history and current activities, followed by a discussion with attendees. Dialogue attendees are welcome to participate in one of three afternoon breakout sessions (research, training, and communications) wherein there will be an opportunity to interact with NCCAM senior staff and discuss how NCCAM and the CAM community can work together in the future. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. Those wishing to attend should register by June 15, 2007. To register, please visit https://nccam.nih.gov/dialogue. For Further Information: To request more information, visit the NCCAM Web site at https://nccam.nih.gov/dialogue, call 1-888-644-6226, or e-mail info@nccam.gov.

The Food and Drug Administration (FDA) is classifying gene expression profiling test systems for breast cancer prognosis 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: Gene Expression Profiling Test System for Breast Cancer Prognosis.'' The agency is classifying the 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 this 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 oxytetracycline hydrochloride soluble powder for skeletal marking of finfish fry and fingerlings by immersion.

This notice announces the 11th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

This notice announces the 16th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

The Food and Drug Administration (FDA) is reopening until June 7, 2007, the comment period for the proposed rule, published in the Federal Register of October 31, 2006 (71 FR 63278). The proposed rule would reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is taking this action in response to two requests for an extension of the comment period for this rulemaking. Elsewhere in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

The Food and Drug Administration (FDA) is reopening to June 8, 2007, the comment period for the notice of availability that appeared in the Federal Register of February 12, 2007 (72 FR 6572). In the notice, FDA requested comments on the draft compliance policy guide on voluntary self-inspection of medicated feed manufacturing facilities. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a system titled, ``End Stage Renal Disease (ESRD) Program Management and Medical Information System (PMMIS), System No. 09-70-0520,'' and last modified at 67 Fed. Reg. 41244 (June 17, 2002). This system contains records on individuals with ESRD who are entitled to receive Medicare benefits or who are treated by Department of Veteran Affairs (DVA) health care facilities. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. The modified routine use will remain as routine use number 1. For further clarity, we propose to separate existing routine use number 3 that permit disclosures to ESRD Network Organizations and to Quality Improvement Organizations into separate routine uses. The activities performed by the 2 different type organizations are not so closely related that they should be combined in one routine use. The modified routine use will be republished as routine use number 3 for ESRD Network Organizations and routine use number 4 for Quality Improvement Organizations. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of priority personal information to complete a transfer out event from a losing ESRD facility and/or a transfer-in event to a gaining ESRD facility to: (1) Contribute to the accuracy of CMS' proper payment of Medicare benefits; and (2) enable such facilities to ensure the proper transfer of health records, and/or as necessary to enable such a facility to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist ESRD programs which may require PMMIS information for purposes related to this system. Information will be released to these organizations upon specific request, and only for those organizations if they meet the following requirements: (1) Provide an attestation or other qualifying information that they are providing assistance to qualified ESRD beneficiaries; (2) submit a report of the transfer-in or transfer-out event; (3) safeguard the confidentiality of the data and prevent unauthorized access; and (4) complete a written statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The PMMIS data will provide the ESRD facility with information regarding its enrollees' enrollment status, transplant activities, dialysis activities, and Medicare utilization; facilitate the facility's required utilization reviews and medication management program activities; and assist in quality of care issues as they relate to the beneficiary. The added routine use will be numbered as routine use number 6. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to maintain information on Medicare ESRD beneficiaries, non-Medicare ESRD patients, Medicare approved ESRD hospitals and dialysis facilities, and Department of Veterans Affairs (DVA) patients. The ESRD/PMMIS is used by CMS and the renal community to perform their duties and responsibilities in monitoring the Medicare status, transplant activities, dialysis activities, and Medicare utilization (inpatient and physician/supplier bills) of ESRD patients and their Medicare providers, as well as in calculating the Medicare covered periods of ESRD. 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 an ESRD Network Organizations; (4) assist Quality Improvement Organizations (QIO) to implement quality improvement programs; (5) facilitate research on the quality and effectiveness of care provided and payment related projects; (6) permit the release of priority personal information to complete a transfer out event and/or a transfer-in event; (7) support litigation involving the agency; and, (8) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to modify or alter existing system of records titled ``Complaints Against Health Insurance Issuers and Health Plans (CAHII),'' System No. 09-70-9005, established at 66 FR 9858, (February 12, 2001). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0516. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 2 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We propose to add 2 new routine uses authorizing disclosure to support a CMS contractor, consultant, or a grantee of a CMS- administered grant program, when disclosure is deemed reasonably necessary by CMS to combat fraud, waste, and abuse in certain health care programs. The new routine use will be published as routine use number 6. We will add a second new routine use to support another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States, when disclosure is deemed reasonably necessary by CMS to combat fraud, waste, and abuse in certain health care programs. This new routine use will be published as routine use number 7. We will broaden the scope of this system by including the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' apply when ever the system collects or maintain PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this system is to collect and maintain information initiated by consumers complaints/reports to CMS that their health insurance issuers and/or non-Federal governmental health plans are in violation of one or more of the following statutes: Sec. Sec. 2722 and 2761 of the Public Health Service (PHS) Act; the Mental Health Parity Act of 1996 (MHPA); the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA); and, the Women's Health and Cancer Rights Act of 1998 (WHCRA). Information maintained in this system 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) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs or to his or her eligibility for, or an entitlement to benefits under the Medicare program; (4) inform a health insurance issuer and/or health plan who has been named in a complaint/inquiry and is believed to be potentially in violation of relevant portions of the PHS; (5) support litigation involving the Agency; and (6) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about this new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

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: ``Chartering Value Exchanges for Value-driven Health Care.'' The information collection will take the form of narrative responses to semiannual Requests for Proposals for participation in a learning network of model multi-stakeholder community health care collaboratives operated to measure, report, and improve the quality and cost of available healthcare. 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.