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

The Food and Drug Administration (FDA) has determined the regulatory review period for TARCEVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 18, 2006, titled ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers'' (71 FR 48354).

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research is announcing the withdrawal of three guidances for industry: ``Providing Submissions in Electronic FormatNDAs,'' ``Providing Regulatory Submissions in Electronic FormatANDAs,'' and ``Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.'' These guidances are being withdrawn because they are no longer consistent with more recent guidance and no longer reflect the agency's preferred format for receiving electronic submissions.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,'' dated September 2006. This guidance provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates and viral seeds used in the production of viral vaccines for human use. This draft guidance, when finalized, will replace the information specific to viral vaccines contained in the 1993 document, entitled ``Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.''

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2006 through June 2006, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare- approved carotid stent facilities. In addition, for the first time, we are also including a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage- related guidance documents, and special one-time notices regarding national coverage provisions. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

NICEATM announces the availability of an addendum to the report, ``Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays'' [NIH Publication 03-4503]. The addendum describes the rationale for revisions to the original list of recommended reference substances for validation of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays.

This notice announces the availability of two interaction profiles prepared by ATSDR [final documents].

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 Sparhawk Laboratories, Inc. The ANADA provides for use of neomycin sulfate soluble powder in livestock for the treatment and control of bacterial enteritis.

The Food and Drug Administration (FDA) has determined the regulatory review period for LYRICA (new drug application (NDA) 21-446) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This notice announces an administrative hearing to be held on November 15, 2006, at the Richard Bolling Federal Building, 601 E. 12th Street, Kansas City, MO 64106-2898, the Kansas City Room, to reconsider CMS' decision to disapprove Missouri State plan amendment 05-11. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 12, 2006.

This notice announces the tenth meeting of the American Health Information Community Consumer Empowerment 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 publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

Section 103(d) of the Americans with Disabilities Act of 1990, Public Law 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention (CDC) published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), and September 27, 2002 (67 FR 61109). The final list has been reviewed in light of new information and has been revised as set forth below.

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 amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Purina Mills, Inc. The supplemental NADA provides for the use of a lasalocid Type A medicated article containing 20 percent lasalocid activity per pound to make free-choice Type C medicated feed mineral blocks used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

This is an update to previous notice that the Food and Drug Administration (FDA) will hold a public meeting October 10, 2006, on nanotechnology as it relates to FDA-regulated products. The primary purpose of this update is to notify the public that preregistration to attend or speak at the public meeting will close on September 29, 2006. The purpose of the meeting is to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products. FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices, whether there are new or emerging scientific issues that should be brought to FDA's attention, and any other scientific issues about which the regulated industry, academia, and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDA-regulated products.

This notice announces the second meeting of the American Health Information Community Quality 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 or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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 option to a co-exclusive commercialization license to practice the inventions embodied in any or all of (a) U.S. patents 5,468,468 (11/21/ 1995); 5,833,986 (11/10/1998); 5,863,739 (01/26/1999); 5,965,359 (10/ 12/1999); 6,228,600 (05/08/2001) and 6,660,488 (12/09/2003), (b) U.S. patent applications 07/308,282 (02/09/1989, now abandoned), 07/915,884 (7/20/1992, now abandoned), 08/439,095 (05/11/1995, pending), 10/ 700,249 (11/03/2003, pending) and (c) foreign applications corresponding to PCT Patent Application PCT/US90/00617 entitled ``Type Alpha Platelet Derived Growth Factor Receptor Gene'', published as WO 90/10013 (9/7/1990) to AstraZeneca Pharmaceuticals LP having a principal place of business in Boston, MA. The prospective option to a co-exclusive license will have a Licensed Territory which is worldwide. The prospective option to the co-exclusive license will have a Field of Use limited to the development of compositions and methods of utilizing antibody-based products that specifically bind the alpha platelet-derived growth factor receptor ([alpha] -PDGFR/CD140a/PDGFRA/PDGF2/PDGFR-[alpha]), for the treatment of cancer and diagnostics specifically useful therewith. Only a single option to a co-exclusive license will be granted. This notice modifies the notice previously published at FR 69(165): 52514-15 (August 26, 2004).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice announces the third 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.)

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 information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements for firms that intend to export certain unapproved medical devices.

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the eleventh meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 2, 2006, and from 9 a.m. to 3 p.m. on November 3, 2006, at the Bethesda DoubleTree Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (71 FR 39686) published on July 13, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0002, ``Indian Health Service Contract Health Service Report.'' Type of Information Collection Request: Extension of a currently approved information collection, 0917-0002, ``Indian Health Service Contract Health Service Report.'' Form Number: IHS 843-1A. Need and Use of Information Collection: The purpose for the collection is to authorize contract health care providers to provide health care services to eligible IHS patients. The IHS form 843-1A ``Order for Health Services'' was developed specifically for this collection of information. Other than revising the title ``Purchase-Delivery Order for Health Services'' to read ``Order for Health Services'', acquisition terms on the front of the form, the contract clauses contained on the back of copy 3 of the form, the form has not been revised and there is no change in the substance or in the use of the form. A copy of the form is at Attachment 2. The majority of the information contained in this form is completed by IHS staff from existing IHS automated patient and vendor data files. Contract health care providers complete and sign the streamlined form and submit it, along with a completed standard Centers for Medicare & Medicaid Services (CMS) health claim form (CMS 1450 (UB 92) and CMS 1500), to the IHS for verification and payment. The CMS forms are used and accepted nation-wide by the health care industry and IHS is an approved user. The information collected is needed to administer and manage the contract health care services provided to eligible American Indian and Alaska Native patients. The form is used to: Authorize contract health care services for eligible patients; certify that the health care services requested and authorized have been performed by the contract provider(s); process payments for health care services performed by such providers; obtain program data; and, serve as a legal document for health and medical care authorized by the IHS and rendered by health care providers under contract with the IHS. The information collected is also used for: Planning for further care of the patient; for keeping an accurate record of the patient's health status and health services received and recommended; for planning future health care programs; for communicating among members of the health care team; for evaluating the health care rendered; for research and continuing education; and, for the provision of program health statistics. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides the estimated burden hours for this information collection:

This document corrects a technical error in the notice that appeared in the Federal Register on September 18, 2006 entitled ``Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible for Calendar Year 2007.'' Effective Date: January 1, 2007.

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 Allied Chemical Corp. Plant, Metropolis, 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 evaluate, subject to revision as warranted by the evaluation, is as follows: Facility: Allied Chemical Corp. Plant. Location: Metropolis, Illinois. Job Titles and/or Job Duties: All workers at Allied Chemical Corp. Plant who were monitored or should have been monitored while they were working in any of the following: Feed Materials Building, Sodium Removal, Uranium Recovery Building, Sampling Plant, Laboratory Building, Ore Storage Locations. Period of Employment: January 1, 1959 to December 31, 1976.

The Food and Drug Administration (FDA) is announcing a public meeting and vendor display to discuss the issues associated with the development, implementation, and use of a unique device identification (UDI) system and the use of various automatic identification technologies. We are inviting individuals, companies, organizations, and other stakeholders to attend this public meeting, which will focus on the development and implementation of a UDI system; the benefits and costs of a UDI system; the use of automatic identification technologies; and the development, maintenance, and use of a repository for UDI related information. We are also inviting vendors of automatic identification technologies to display their products for the educational benefits of FDA and other attendees.

This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment allows certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This final rule also requires that nursing facilities at least install battery-operated single station smoke alarms in resident rooms and common areas if they are not fully sprinklered or they do not have system-based smoke detectors in those areas. Finally, this final rule confirms as final the provisions of the March 25, 2005 interim final rule with changes and responds to public comments on that rule.

The Food and Drug Administration (FDA) has determined the regulatory review period for MACUGEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for FUZEON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Public Availability of Labeling Changes in `Changes Being Effected' Supplements.'' The guidance announces to holders of a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), who intend to submit a ``Changes Being Effected'' supplement (CBE supplement) to make a postapproval labeling change, that FDA will make labeling revisions identified in a CBE supplement publicly available upon receipt of the supplement by FDA. The guidance does not have any bearing on supplements that relate to chemistry, manufacturing, and controls changes, nor does it expand the circumstances in which an ANDA holder may effect labeling changes via a CBE supplement.

The Food and Drug Administration (FDA) has determined the regulatory review period for CYDECTIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

HRSA is requesting comments on the future direction and strategy regarding investments in health information technology (HIT) for section 330 grantees and other HRSA safety-net providers through its Office of Health Information Technology (OHIT). OHIT will evaluate all comments received during the public comment period to inform OHIT's policy direction.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2007. This premium is to be paid by enrollees age 65 and over who are not otherwise eligible (hereafter known as the ``uninsured aged'') and for certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2007 for these individuals will be $410. The reduced premium for certain other individuals as described in this notice will be $226. Section 1818(d) of the Social Security Act specifies the method to be used to determine these amounts.

The objective of this project is to mitigate any potential global shortage of influenza vaccines and the manufacturing of this vaccine in the event of an influenza pandemic. The Office of Public Health Emergency Preparedness (OPHEP) requires the World Health Organization (WHO) to perform activities related to pandemic influenza preparedness and planning, particularly in the international development of H5N1 human vaccines (and other pandemic influenza vaccine candidates) and influenza vaccine manufacturing infrastructure building in countries where resources for vaccine acquisition and manufacturing may be limited. The specific countries in which the WHO Secretariat will carry out these activities are Argentina, Brazil, India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. Activities include pre-clinical safety and immunogenicity testing, toxicology testing, clinical vaccine lot manufacturing, scale-up and process development, analytical lot release assay development and validation, and clinical immunogencity assay development and validation.

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: NCI Cancer Information Service Base Demographics/Customer Service Data Collection. Type of Information Collection Request: Revision of currently approved collection 0925- 0208. Need and Use of Information Collection: The National Cancer Institute's Cancer Information Service (CIS) provides the latest information on cancer, clinical trials, and tobacco cessation. Characterizing clients and how they found out about the CIS is essential to customer service, program planning and promotion. This effort involves a brief survey of clients of the 1-800-4-CANCER and 1- 877-44U-QUIT toll-free services and LiveHelp, a web-based chat service. The telephone survey contains eight questions3 customer service and 5 demographicasked of a subset of callers (cancer patients, tobacco users, their family or friends, and the general public) at the end of usual service for an annual total of approximately 115,944 callers. All (100%) of these telephone clients will be asked the 3 customer service questions for an annual total of 113,061 callers. Of the 113,061 telephone clients we serve annually, 36% (n=40,702) will be randomly selected and asked five additional demographic questions. The LiveHelp web survey involves 50% of LiveHelp clients the same eight questions (3 customer service questions and 5 demographic questions) for an annual total of approximately 2,883 users. The combined total of clients to be surveyed each year for both telephone and LiveHelp services is 115,944 for a total of annual burden hours of 2,616. Frequency of Response: Single time. Affected Public: Individuals or households. Type of Respondents: Patients, relatives, friends, and general public. The annual reporting burden is as follows: Estimated Number of Respondents: 115,944; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.0167 and Estimated Total Annual Burden Hours Requested: 2616. The annualized cost to respondents is estimated at: $47,323. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Chronic Condition Data Repository (CCDR), System No. 09-70-0573.'' The program is mandated by Section 723 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The CCDR program seeks to establish a data repository to study chronically ill Medicare beneficiaries. This data repository will integrate existing data to support studies for improving the quality of care and studies for reducing the cost of care for chronically ill Medicare beneficiaries. The statute is designed to reduce program spending, make current Medicare program data more readily available to researchers to study chronic illness in the Medicare population, improve process time for research data request, focus on analytic prospective verses operational, and utilize data extraction tools to organize the data. The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, System No. 09-70-0553 (70 Federal Register (FR) 58436 (October 6, 2005)); Medicare Beneficiary Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical Information System, System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common Working File, System No. 09-70- 0526 (67 FR 3210 (January 23, 2002)); National Claims History, System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 (August 22, 2002)); Intermediary Medicare Claims Record, System No. 09-70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider Identification Number, System No. 09-70-0525 (69 FR 75316 (December 16, 2004)); Medicare Supplier Identification File, System No. 09-70-0530 (67 FR 48184 (July 23, 2002)), A Current Beneficiary Survey, System No. 09-70-6002 (66 FR 15496 (March 19, 2001)); National Plan & Provider Enumerator System, System No. 09-70-0008, (63 FR 40297 (July 28, 1998)); Long Term Care MDS, System No. 09-70-1517 (67 FR 6714 (February 13, 2002)); HHA Outcome and Assessment Information Set, System No. 09-70-9002 (66 FR 66903 (December 27, 2001)); and Integrated Data Repository, System No. 09-70-0571 (To be published). The purpose of this system is to collect and maintain a person- level view of identifiable data to establish a data repository to study chronically ill Medicare beneficiaries. This system will utilize data extraction tools to support accessing data by chronic conditions and process complex customized research data requests related to chronic illnesses. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support Quality Improvement Organizations (QIO); (5) support litigation involving the agency; and (6) combat fraud, waste, and abuse in certain Federally-funded 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.

This 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 5,830,755 filed March 27, 1995 [HHS Ref. No. E-093-1995/0-US-01] and Australian Patent 709122 filed March 27, 1996 [HHS Ref. No. E-093- 1995/0-AU-03], entitled T-Cell Receptors and Their Use in Therapeutic and Diagnostic Methods, to CellCure A/S, which is located in Aarhus, Denmark. 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 a complete T-cell receptor MART-1 peptide restricted by HLA-A2 incorporated into a continuous T-Lymphocyte cell line developed or owned by licensee to treat cancer.

The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) published in the Federal Register of May 12, 2006 (71 FR 27606), a direct final rule to amend the regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products. The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. The agencies will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published as a companion to the direct final rule (71 FR 27649).

This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panam[aacute] and (b) train community health workers and clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America, (c) facilitate partnerships (``twinning'') between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health training and program efforts in Latin America. These efforts will contribute to improved and expanded provision of prevention and primary health care, and they will help engage significantly more areas of these countries to prepare for and respond to public health emergencies such as pandemic influenza. The training efforts of this project will place greater emphasis on the training of nurses and community health workers, rather than physicians, to reap the greatest improvement in expanded coverage and improved access to community, preventive and primary health care in underserved parts of Latin America (i.e., underserved rural and poor urban communities). In addition, as a result, the healthcare work force will be better prepared to respond to public health emergencies such as pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to commit to providing their health and medical care skills in underserved areas within the region. In addition to all appropriate medical care and health education or communication subjects, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, among other subjects so graduates of training programs will be prepared to play contributing roles to any pandemic preparation and response.

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). Proposed Collection: Title: California Health Interview Survey (CHIS) 2007 Cancer Control Module (CCM). Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored three Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fourth to be administered in 2007. Other Federal government agencies have co- sponsored previous cycles of the survey. The CHIS is a telephone survey designed to provide population- based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults, 5,801 adolescents, and 12,802 children; subsequently in 2003 to 42,043 adults, 4,010 adolescents, and 8,502 children; and in 2005 to 43,020 adults, 4,029 adolescents, and 11,358 children. These individuals are a representative sample of California's non- institutionalized population living in households. CHIS 2007, the fourth bi-annual survey, is planned for administration to 48,000 adult Californians. The cancer control module, which is similar to that administered in CHIS 2001, CHIS 2003, and CHIS 2005, will allow NCI and other Federal agencies to examine various health- and disease-related topics. Examples include patterns and (when fielded in multiple years) trends in breast cancer screening, diet, physical activity, obesity, tobacco control and other disease risk factors, disease outcomes, discrimination, and neighborhood cohesion. Because California is the most populous and the most racially and ethnically diverse state in the nation, the CHIS 2007 sample will yield adequate numbers of respondents in key ethnic and racial groups, including African Americans, Latinos, Asians, and American Indian/ Alaska Natives. The Latino group will include large numbers of respondents in the Mexican, Central American, South American, and other Latino subgroups; the Asian group will include large numbers of respondents in the Chinese, Filipino, Japanese, Vietnamese, and Korean subgroups. NCI and other Federal agencies will use the California and National Health Interview Survey (CHIS, NHIS) data to conduct comparative analyses and better estimate cancer risk factors and screening among racial/ethnic minority populations. The CHIS sample size also permits NCI and other federal agencies to obtain estimates for ethnic subdomains of the population, for which NHIS has insufficient numbers for analysis. Frequency of Response: One-time. Affected public: Individuals or households. Types of Respondents: U.S. adults (persons 18 years of age and older) and adolescents (persons of age 12-17 for whom the adult respondent is the parent or legal guardian of the adolescent residing in the household). The annual reporting burden is as follows.

This notice announces the ninth meeting of the American Health Information Community (``Community'') Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)