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

The HRSA HIV/AIDS Bureau (HAB) Policy Notice 99-02 entitled, The Use of Ryan White CARE Act funds for Housing Referral Services and Short-term or Emergency Housing Needs, provides grantees with guidance on the use of Ryan White Comprehensive AIDS Resources Emergency (CARE) Act funds for short-term and emergency housing assistance for persons living with HIV/AIDS. The current policy does not establish a time limit for such assistance under the Ryan White CARE Act. An amendment to Policy Notice 99-02 is proposed, which places a cumulative lifetime period of 24 months on short-term and emergency housing assistance under the Ryan White CARE Act. This proposed amendment results from an Office of Inspector General audit encouraging HRSA to clarify the definition of short-term housing and emergency housing assistance. This amendment will help align the HRSA definition of short-term housing with the widely accepted program standard used by the U.S. Department of Housing and Urban Development, Continuum of Care Homeless Assistance Programs and the Housing Opportunities for Persons with AIDS program. This policy becomes effective March 1, 2007.

This notice amends the announcement of the tenth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending OMB approval on the existing recordkeeping requirements for this information collection, regarding animal proteins prohibited in ruminant feed.

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, established at 66 Federal Register (FR) 63392 (December 6, 2001), and modified at 71 FR 11420 (March 7, 2006). The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) authorizes Medicare payment to Part D sponsors (including Medicare Advantage prescription drug plan sponsors) that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 CFR Parts 417, 422 and 423. The MBD will include data necessary to process certain activities associated with the new Part D benefit including, but not limited to, 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, and regulation, 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). We propose to broaden the scope of the disclosure provisions of this system by adding a new routine use to permit the release of Part D enrollment data maintained in the MBD to support Patient Assistance Programs (PAP) and other groups providing pharmaceutical assistance to the Medicare beneficiary. The new routine use will be published as routine use number 8. Specifically, the new routine use will facilitate the sharing of information between PAPs and Part D plans to meet the MMA provisions for drug utilization reviews, drug medication therapy management, and quality of care that can only be addressed through the cooperation between the PAP and the Part D Plan. Information may be released to these organizations upon a specific request, and only if the requester meets the following requirements. They must (1) Provide an attestation or other qualifying information that they are providing pharmaceutical assistance to Medicare beneficiaries; (2) submit a finder file identifying Medicare beneficiaries receiving pharmaceutical assistance and/or services; (3) safeguard the confidentiality of any CMS data received and prevent unauthorized access; and, (4) complete a written statement attesting to the information recipient's understanding of and willingness to abide by CMS provisions regarding Privacy protections and information security. Recipients of CMS data must complete the Coordination of Benefits PAP Data Sharing Agreement prior to the release of CMS data. The finder file submitted by the PAP must provide the following data elements: (a) First initial of the first name, (b) first 6 letters of the last name, (c) social security number or health insurance claims number, (d) date of birth, and (e) sex. Part D data maintained in the MBD that will be released to a PAP or a group providing pharmaceutical assistance will consist of the verification of Medicare status and the identification of the current Part D Plan selected by the Medicare beneficiary. We will delete published routine use number 8 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 will broaden the scope of published routine uses number 10 and 11 authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which shall refer to specific beneficiary/recipient practices that result in unnecessary cost to all federally-funded health benefit programs. The primary purpose of this modified system is to provide CMS with a singular, authoritative, database of comprehensive enrollment 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's Medicare health insurance coverage and Medicare health plan and demonstration enrollment. 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 a CMS 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 Patient Assistance Programs and other groups providing pharmaceutical assistance or services to Medicare beneficiaries; (9) support litigation involving the agency; and (10) combat fraud, waste, 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.

The Food and Drug Administration (FDA) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for oral use of pyrantel pamoate suspension in horses and ponies as an over-the-counter (OTC) animal drug product for the removal and control of various internal parasites.

Under the provisions of section 3507(a) (1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 14, 2006, page 46486 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.

This final rule with comment period addresses certain provisions of the Deficit Reduction Act of 2005, as well as making other changes to Medicare Part B payment policy. These changes are intended to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period 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 (BMM) services, independent diagnostic testing facilities (IDTFs), 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, the health care information transparency initiative; updates the list of certain services subject to the physician self-referral prohibitions, finalizes ASP reporting requirements, and codifies Medicare's longstanding policy that payment of bad debts associated with services paid under a fee schedule/charge- based system are not allowable. We are also finalizing the calendar year (CY) 2006 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2007. In addition, this rule includes revisions to payment policies under the fee schedule for ambulance services and the ambulance inflation factor update for CY 2007. As required by the statute, we are announcing that the physician fee schedule update for CY 2007 is -5.0 percent, the initial estimate for the sustainable growth rate for CY 2007 is 2.0 percent and the CF for CY 2007 is $35.9848.

The Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Fiscal Year 2008 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2007 through September 30, 2008. This notice announces the calculated ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that we will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures, and Temporary Assistance for Needy Families (TANF) Contingency Funds, the federal share of Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. Programs under title XIX of the Act exist in each jurisdiction; programs under titles I, X, and XIV operate only in Guam and the Virgin Islands; while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. Programs under title XXI began operating in fiscal year 1998. The percentages in this notice apply to State expenditures for most medical services and medical insurance services, and assistance payments for certain social services. The statute provides separately for Federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Act require the Secretary of Health and Human Services to publish the Federal Medical Assistance Percentages each year. The Secretary is to calculate the percentages, using formulas in sections 1905(b) and 1101(a)(8)(B), from the Department of Commerce's statistics of average income per person in each State and for the Nation as a whole. The percentages are within the upper and lower limits given in section 1905(b) of the Act. The percentages to be applied to the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states. The ``Federal Medical Assistance Percentages'' are for Medicaid. Section 1905(b) of the Act specifies the formula for calculating Federal Medical Assistance Percentages as follows:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Bertek Pharmaceuticals, Inc., to Mylan Bertek Pharmaceuticals, Inc.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Subjects for Delayed Adverse Events,'' dated November 2006. The guidance document provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Participants for Delayed Adverse Events,'' dated August 2005, and supplements the recommendations for study subject long-term follow-up in the ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors'' (Retroviral Vector guidance), dated November 2006.

The Food and Drug Administration (FDA) is announcing a public meeting on improving patient safety by enhancing the container labeling for parenteral infusion drug products. This will be a 1-day workshop involving FDA staff and representatives of the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The purpose of the meeting is to explore how labels on intravenous (IV) drug products could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label.

The Food and Drug Administration (FDA) is extending the comment period on the draft guidance entitled ``Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.'' FDA announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52799). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period.

This proposed rule would modify Medicare regulations to implement a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules or ``ERS''). Under this provision, we propose to grant a provider or a supplier an extended repayment schedule under certain terms and conditions as defined in the statute. The proposed rule would establish criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.''

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: James C. Lin, Ph.D., University of Illinois at Chicago: Based on the findings from an inquiry by the University of Illinois at Chicago (UIC) and on additional analysis conducted by ORI during its oversight review, the U.S. Public Health Service (PHS) found that James C. Lin, Ph.D., Professor, Department of Electrical and Computer Engineering, Physiology, and Biophysics, UIC, engaged in research misconduct concerning National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant application 1 R01 NS47238-01, ``Blood-Brain Barrier Interactions of Cellular-Phone Radi.'' Specifically, PHS found that Dr. Lin committed research misconduct relative to the legend and related text for Figure 2 (data from a colleague on other experiments) for his NIH application 1 R01 NS47238- 01, by falsely claiming the figure represented preliminary results of his independent experiments that differed from the source of the figure and the prior research in the field, in which he purported to have selectively exposed the rat's head to microwave irradiation, to have utilized higher peak exposure, of shorter duration and of different radio frequencies, and which reported injury of more acute nature to the blood barrier. Dr. Lin denies all allegations of research misconduct and contends that some of his original data is missing as a result of the involuntary relocation of his laboratory. Dr. Lin makes no admission of guilt in connection with the charges or PHS' findings of research misconduct herein. Both Dr. Lin and PHS are desirous of concluding this matter without further expense of time and other resources. Dr. Lin has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on October 24, 2006: (1) That any institution which submits an application for PHS support for a research project on which Dr. Lin's participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS-funded research in which Dr. Lin is involved, must concurrently submit a plan for supervision of Dr. Lin's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of his research contribution. Dr. Lin agrees to ensure that a copy of the supervisory plan also is submitted to ORI by the institution. He also agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; (2) that any institution employing Dr. Lin submit in conjunction with each application for PHS funds or reports, manuscripts, or abstracts of PHS-funded research in which Dr. Lin is involved a certification that the data provided by Dr. Lin are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report. Dr. Lin must ensure that the institution also sends a copy of the certification to ORI; and (3) to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non- Corrective Contact Lenses.'' This guidance document explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). All contact lenses, including decorative, non-corrective contact lenses, require premarket approval or clearance by FDA and may be dispensed only upon a lawful prescription order by an eye care professional. Although this guidance document is being immediately implemented, the agency welcomes comments at any time in accordance with the agency's good guidance practices (GGPs).

This notice announces the availability of one new and five updated final toxicological profiles of priority hazardous substances comprising the eighteenth set prepared by ATSDR.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum level and Enforcement Policy,'' and a supporting document entitled ``Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children.'' The guidance provides a maximum recommended lead level in candy likely to be consumed frequently by small children. FDA considers the recommended maximum level to be protective of human health and to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients. The guidance states FDA's commitment to take enforcement action against candy containing lead at levels that may pose a health risk. These two documents are intended to assist candy manufacturers in achieving reduced lead levels in their products consistent with the agency's policy of reducing lead levels in the food supply to reduce consumers' lead exposure to the lowest level that can practicably be obtained.

This notice announces a listening session being conducted as part of the development of a plan for Medicare hospital value-based purchasing, as authorized by the section 5001(b) of the Deficit Reduction Act (DRA) of 2005. The purpose of the listening session is to solicit comments on the range of design issues being considered for plan development. Hospitals, hospital associations, and all interested parties are invited to attend and make comments in person. It will also be possible to participate by teleconference, although due to time constraints, telephone participants will not be able to make verbal comments. Written comments are welcomed. The perspectives expressed during this session and in writing will assist us in drafting the plan. An issues paper outlining the design questions to be discussed and further information about the January listening session will be posted no later than January 3, 2007 on the CMS Web site, Hospital Center, under Spotlights at https://www.cms.hhs.gov/center/hospital.asp.

This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). One vacancy presently exists on the Panel due to a Panel member's retirement in June 2006. There will be six more vacancies on the Panel between January 1 and September 30, 2007. Consequently, this solicitation is for seven new members. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as we prepare our annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking. The Secretary rechartered the Panel in 2004 for a 2-year period through November 21, 2006. The new Panel Charter will be effective through November 21, 2008. Nominations: We will consider nominations if they are received no later than 5 p.m. on December 18, 2006. Please mail or deliver nominations to the following address: CMS; Attn: Shirl Ackerman-Ross, Designated Federal Official (DFO), Advisory Panel on APC Groups; Center for Medicare Management, Hospital & Ambulatory Policy Group, Division of Outpatient Care; 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. Web Site: For additional information on the APC Panel and updates to the Panel's activities, search our Web site at the following: http:/ /www.cms.[fxsp0]hhs.gov/FACA/05 [fxsp0]AdvisoryPanelonAmbulatory[fxsp0]PaymentClassificationG roups.[fxsp 0]asp#TopOfPage. Advisory Committees' Information Lines: You may also refer to the CMS Federal Advisory Committee Hotlines at 1-877-449-5659 (toll-free) or 410-786-9379 (local) for additional information.

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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment.'' Sinusitis is a common disease affecting an estimated 16 percent of the adult U.S. population annually. At present, other than antimicrobials, the treatment options for sinusitis are limited. This guidance is intended to assist the pharmaceutical industry in designing clinical development programs for nonantimicrobial drug products for the treatment of sinusitis.

This notice announces the notification and obligation of the Federal Employee Antidiscrimination and Retaliation Act of 2002 (No Fear Act). This notice is in compliance with the notification provisions set forth in Title II of the Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002. The No FEAR Act requires that all Federal agencies publish an initial notice in the Federal Register informing Federal employees, former Federal employees, and applicants of the rights and protections available to them under Federal antidiscrimination and whistleblower protection laws.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health. The first supplemental NADA revises the concentrations of ractopamine hydrochloride in single-ingredient Type B and C medicated swine feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness. The other supplemental NADA revises the concentrations of ractopamine hydrochloride used with tylosin phosphate in two-way Type C medicated swine feeds to conform with approved single-ingredient ractopamine use.

National Heart, Lung, and Blood Institute (NHLBI) seeks partners in a biomarker consortium to promote research on novel serum/ plasma/urine biomarkers of cardiovascular disease (CVD) and related risk factors including atherosclerosis, obesity, insulin resistance, hypertension, and metabolic syndrome. An immediate consequence of this project will be the development of new diagnostic tests to identify individuals at high risk for CVD and its risk factors at a time when intervention is most feasible. A downstream result of the identification of novel biomarkers of CVD (and its risk factors) will be the discovery of disease promoting pathways, which may serve as new therapeutic targets for treating and preventing our nation's leading cause of death. Background: Despite steady declines in CVD mortality, CVD remains the leading cause of death in the developed world. The NHLBI's Framingham Heart Study (FHS) has been instrumental in the identification and elucidation of key modifiable risk factors for CVD, which in turn have facilitated modern approaches to the prevention and treatment of CVD. Because of its prospective study design, the NHLBI's FHS is ideally positioned to enable identification of novel risk factors for CVD. The availability of frozen serum/plasma/urine samples from over 7000 FHS participants in the Offspring and Third Generation cohorts, in concert with new high-throughput quantitative biomarker technology available from commercial collaborators, provides a unique opportunity to explore the biochemical signatures of key CVD phenotypes. In addition, by the end of 2007 genotyping of 550k SNPs will be completed in nearly all the FHS participants as part of the NHLBI's SHARe project and these data will permit analysis of the associations of gene variants with biomarker levels. Scientific Scope: The proposed study will measure 150 or more evolving and novel biomarkers from the FHS in 7000 FHS subjects for whom subclinical and clinical CVD and its risk factors have been carefully characterized. Analyses will be conducted for association of biomarkersindividually and collectivelywith clinically relevant phenotypes. The aims of the project are to: 1. Identify the biochemical signature of atherosclerosis as determined by: (a) Aortic and coronary calcification on CT (data available in 3500 people), (b) aortic plaque burden by MRI (n=2000), (c) carotid intimal-medial thickness by ultrasound (n=3500), (d) clinical atherosclerotic CVD (n=500), and (e) the dynamic balance between arterial calcification and bone demineralization (n=3500). 2. Identify the biochemical signature of metabolic syndrome components including (a) systolic and diastolic blood pressure (n=7000), (b) obesity (n=7000) and visceral adiposity by CT (n=3500), (c) dyslipidemia (n=7000), and (d) impaired fasting glucose, diabetes, and insulin resistance. Biomarkers for this project will be selected by expert consensus on the basis of (a) a careful review of the literature for biomarkers of atherosclerosis and metabolic syndrome, and (b) genes implicated in atherosclerosis and metabolic syndrome (and their constituent components and pathways), or showing evidence of association with the phenotypes of interest. Technology: As part of this project, new quantitative tests will be developed to measure circulating biomarker levels using antibody sandwich assays and/or proteomic approaches that are amenable to high throughput application. Critical to this project is the implementation of methods to measure large numbers of biomarkers with minimal sample volume; proteomic, bead-linked immunoassays, and nanotechnology methods may be necessary to accomplish this aim. Pathways to be studied include but are not limited to: Adhesion/chemoattraction, adipokines, cytokines, growth factors, heat shock proteins, inflammation, lipoproteins, neurohormones, thrombosis/fibrinolysis, and vascular calcification. Demonstrated rigorous assay validation using non-FHS samples will be necessary before FHS biospecimens can be used for this project. Study Sample: The NHLBI's FHS is community-based[N1], which should contribute to the generalizability of study results. Frozen serum/plasma/urine samples and buffy coats for WBC derived RNA are available in two carefully characterized cohorts comprising over 7000 individuals. The presence of young, middle-aged, and elderly subjects will allow a more complete exploration of biomarkers for relevant traits across a wide age range (20-90 years). The FHS main contracts (N01-HC-38038; N01-HC-25195) have provided for the core examinations of the participants that include physical examination, ECG, multidetector CT scans for coronary calcification and visceral adiposity, and blood specimen collection. In addition, buffy coats and purified white blood cell RNA also are available for WBC- derived RNA expression profiling to complement circulating biomarker and genotypic characterization.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``National Claims History (NCH),'' System No. 09-70-0005, last published at 67 FR 57015 (September 6, 2002). 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. 09-70-0558. We propose to modify existing routine use number one 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 one. We will broaden the scope of routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We will delete routine use number six 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 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 modified system is to collect and maintain billing and utilization data on Medicare beneficiaries enrolled in hospital insurance (Part A) or medical insurance (Part B) of the Medicare program for statistical and research purposes related to evaluating and studying the operation and effectiveness of the Medicare program. The 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) assist QIOs; (6) process individual insurance claims by other insurers; (7) facilitate research on the quality and effectiveness of care provided, as well as payment- related projects; (8) support litigation involving the agency; and (9) combat fraud, waste, and abuse in Federally-funded 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 modified or altered 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, we are proposing to modify or alter an existing SOR, ``Record of Individuals Authorized Entry to the Health Care Financing Administration (HCFA) Building via a Card Key Access System (RICKS), System No. 09-70-3001'' last modified 66 FR 15264 (March 16, 2001). The name of the Agency has been changed from HCFA to the Centers for Medicare & Medicaid Services (CMS). We will modify the system name to read: ``Record of Individuals Authorized Entry to the CMS Building via a Card Key Access System (RICKS).'' 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 HCFA systems of records. The new assigned identifying number for this system should read: System No. 09-70-0518. 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 3 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 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 issue and control United States Government card keys to all CMS employees and other authorized individuals who require access into certain designated or secured areas. 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 agency to conduct activities related to this system; and (3) support litigation involving the agency. 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.

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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing system of records titled, ``Unique Physician/Practitioner Identification Number (UPIN),'' System No. 09-70-0525, most recently modified at 69 FR 75316 (December 16, 2004). We propose to delete published routine use number 1 that permits the release of the identification of each physician or non-physician practitioner who has been assigned a UPIN and who is participating in the Medicare program. Selected UPIN information to carry out this requirement is available as a public use file, and as such, should not be treated as a routine use disclosure. We will broaden the ``Purpose'' section of this notice to include this requirement as one of the primary purposes of this system. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charges 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 be renumbered as routine use number 1. We will delete routine use number 6 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 will broaden the scope of routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We also propose to add a routine use for the release of information to assist an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment-related projects. The added routine use will be numbered as routine use number 3. 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 SOR is to: (1) Collect and maintain an unique identification of each physician, non-physician practitioner, or medical group practice requesting or receiving Medicare payment, and (2) provide beneficiaries and other interested entities with the identification of each physician or non-physician practitioner assigned an UPIN and who are participating in the Medicare program. Information retrieved from this SOR will be used to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant, or CMS grantee; (2) assist another Federal and/or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (4) assist Quality Improvement Organizations; (5) provide the American Medical Association with information needed for them to assist us in identifying physicians; (6) support litigation involving the Agency; and (7) combat fraud, waste, 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 proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is announcing the availability of a final Compliance Policy Guide (CPG) 160.900 entitled ``Prescription Drug Marketing ActPedigree Requirements under 21 CFR Part 203'' (PDMA CPG). This CPG describes how the agency intends to prioritize its enforcement efforts in the first year after the December 1, 2006, effective date of 21 CFR Sec. Sec. 203.3(u) and 203.50. In addition, the FDA is announcing the availability of ``Guidance for Industry: Prescription Drug Marketing Act (PDMA) Pedigree Requirements Questions and Answers'' (PDMA Q & A). The PDMA Q & A guidance is issued in response to the many questions received regarding the Prescription Drug Marketing Act (PDMA) pedigree requirements. The two guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the PDMA.

The Food and Drug Administration (FDA) is amending the animal drug regulations to simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin sodium. This action is being taken to improve the clarity of the regulations.

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 NIEHS and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) request public comments that can be considered by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and agency program offices in development of a NICEATM/ICCVAM 5-year plan that addresses: (1) Research, development, translation, and validation of new and revised non-animal and other alternatives assays for integration of relevant and reliable methods into federal agency testing programs and (2) identification of areas of high priority for new and revised non-animal and alternative assays for the replacement, reduction, and refinement (less pain and distress) of animal tests.

This notice announces an administrative hearing to be held on December 29, 2006, at the Colorado State Bank Building, 1600 Broadway, Suite 700, Keystone Conference Room, Denver, CO 80202-4967, to reconsider CMS' decision to disapprove Colorado State plan amendment 05-006. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by November 28, 2006.

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.