Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of September 23, 1997, entitled ``Food Labeling; Nutrient Content Claims; Definition for ``High Potency'' and Definition of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods.'' This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

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: J. Keith Hampton, St. Luke's Hospital: Based on the report of an investigation conducted by St. Luke's Hospital (SLH) in Chesterfield, MO, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that J. Keith Hampton, MSN, APRN, former Clinical Research Associate, SLH, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards U10 CA69651, U10 CA12027, and U10 CA33601. PHS found that Mr. Hampton engaged in scientific misconduct by falsifying and fabricating data that were reported to the National Surgical Adjuvant Breast & Bowel Project (NSABP) and Cancer and Leukemia Group B (CALGB) cooperative research groups. Specifically, PHS found that: 1. For protocol CALGB 90206, Respondent: (a) Falsified a patient's CT scan reports and registration forms and reported the falsified CT scan reports and registration worksheet to CALGB, (b) Falsified a patient's performance status records (giving 80% performance status) and registration forms and reported the falsified performance status report and registration form to CALGB. 2. For protocol NSABP B-35, Respondent: (a) Falsified eligibility data related to hematology and chemistry assays and to the performance of a pelvic exam on one patient's registration form and reported the falsified registration forms to the National Cancer Institute Cancer Trial Support Unit (CTSU), (b) Falsified pelvic exam eligibility on a second patient's registration form and reported the falsified registration form to the CTSU, (c) Falsified hematology and chemistry assay eligibility on a third patient's registration form and reported the falsified registration form to the CTSU. 3. For protocol NSABP B-36, Respondent falsified a patient's multigated acquisition test (MUGAa test of heart function) records, cardiac function, and registration forms, certified the patient's eligibility, and reported the falsified MUGA test, cardiac function, and registration forms to the CTSU. 4. For protocol NSABP B-38, Respondent falsified hematology, chemistry, and MUGA eligibility for a patient on the registration form and reported the falsified registration form to the CTSU. 5. For protocol NSABP C-08, Respondent: (a) Falsified urine protein/creatinine ratio eligibility for one patient on the registration form and reported the falsified registration form to the CTSU, (b) Falsified urine protein/creatinine ratio eligibility for a second patient on the registration form and reported the falsified registration form to the CTSU, (c) Falsified claims of the urine protein/creatinine ratio and PT(INR) eligibility for a third patient on the registration form and reported the falsified registration form to the CTSU. 6. For protocol NSABP R-04, Respondent falsified a patient's colonoscopy report and eligibility at registration and reported the falsified colonoscopy report and registration form to the CTSU. Mr. Hampton has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed for a period of three (3) years, beginning on June 17, 2008: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq.) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR part 180); and (2) 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 or contractor to PHS.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency,'' dated June 2008. The guidance document provides recommendations for the design of clinical trials to assess the safety, efficacy, and pharmacokinetics of immune globulin intravenous (human) (IGIV) products as replacement therapy in primary humoral immunodeficiency. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2005.

The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers'' that will serve as the special control for these devices.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.'' The guidance document describes a means by which bone sonometers may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health Care Systems for Tracking Colorectal Cancer Screening Tests.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 27th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Changes were made to this 30 day notice to account for the electronic patient records review which were not accounted for in the 60 day notice.

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

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 3 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacturer of products distributed within the United States.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (FAC), Center for Food Safety and Applied Nutrition (CFSAN). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Surveillance and Detention Without Physical Examination of Condoms.'' This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of condoms from manufacturers/shippers whose condoms have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that condoms imported to the United States do not have defects that could compromise their effectiveness and present a health hazard to consumers who rely on condoms for protection from sexually transmitted diseases as well as for contraception.

The Food and Drug Administration (FDA) is seeking third-party certification bodies that certify foreign processors of aquacultured shrimp for compliance with FDA's Seafood Hazard Analysis and Critical Control Point (HACCP) regulations to volunteer to participate in a pilot program to be conducted by FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA). The goal of the pilot program is to gather technical and operational information that will assist FDA in determining its infrastructure needs, as well as the process for evaluating third-party certification programs, in order to assist FDA in moving towards broader recognition of voluntary third-party certification programs, including third-party certification programs for aquacultured shrimp, at a later time.

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 is for planning purposes only. It does not constitute a solicitation or Request for Proposal (RFP), nor does it restrict the Government as to the ultimate acquisition approach. The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information solicited. Any contract that might be awarded based on information received or derived from this RFI will be the outcome of the competitive process. Any purchases that might result from information received or derived from this RFI will be at the discretion of the Government. Purpose: To ensure development of a rigorous and comprehensive battery of HTS assays, the NTP seeks information and comments on the identification and selection of critical cellular toxicity pathways for interrogation in cell-based high throughput screens. The NTP is also interested in receiving recommendations on particular molecular targets within these critical cellular toxicity pathways that are most informative for profiling the pathways, both in cell-based and biochemical assay formats. In addition to information on cellular pathways and targets, the NTP seeks information on technologies and assay systems that might be used in the development of a comprehensive approach to high throughput toxicity screening. Responses to RFI: The Government requests a brief (no more than 1 page) description of the proposed presentation addressing one or more of the points listed below or other directly related topics. In considering responses to this RFI, please keep in mind the assay protocol requirements for assays run at the NIH Chemical Genomics Center (NCGC) (https://www.ncgc.nih.gov/guidance/HTS_Assay_Guidance_ Criteria.html ). Recommendations on the identification and selection of critical cellular pathways involved in toxicity and associated with a phenotypic manifestation of toxicity in vivo (disease outcome). Information on assays that can be used to measure the activity of a compound on a target within a critical pathway. Information on the selection of the best targets within pathways and networks in order to accurately and fully characterize the activity of a compound within a specific pathway or the ability of a compound to trigger a stress-responsive pathway resulting in a defined toxicity or disease. Information on assays, technologies, or methods that will aid in identifying compounds which are active only after metabolic activation. New technologies or technologies under development that can be exploited in HTS programs, such as those underway at the NCGC or as secondary, targeted, follow-up testing to expand and more carefully characterize the findings from initial screens. All responses should include the following information: Company name, company address, name of presenter, telephone number, and e-mail address. Responses should be submitted by August 11, 2008, either electronically via the meeting Web site or by fax, e-mail, or mail to: Jennifer Smith, Contract Specialist, NIEHS, P.O. Box 12874, Mail Drop EC-02, 79 T.W. Alexander Drive, Building 4401, Room 134, Research Triangle Park, NC 27709; fax: 919-541-2712; e-mail: smithj3@niehs.nih.gov. Responses will be reviewed to ensure that the Government, by extending an invitation to a party to participate in the RFI meeting, will receive information directly relevant to its HTS program for toxicity assessment and that the party fully understands the nature of the meeting and the type of information sought. Acknowledgement of receipt of responses will not be made nor will respondents be notified of the Government's assessment of the information received. No basis for claims against the Government shall arise as a result of a response to this request for information or in the Government's use of such information as either part of its evaluation process or to develop specifications for any subsequent announcement. Responses will not be returned. The summarized responses (without identifiers) may appear in internal reports or be made public. Although the NIH will provide safeguards to prevent the release of identifying information, there is no guarantee of confidentiality. Attendance and Registration: An informational public meeting will be held on September 11-12, 2008, at the National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Attendance at the meeting is limited only by the available space. The purpose of this meeting is for interested parties to provide the Government information about assays, molecular targets, and cellular pathways through brief presentations and a question and answer session. Parties interested in making a presentation at the meeting must register on the meeting Web site: (https://ntp.niehs.nih.gov/go/32908). Attendees not making presentations are also encouraged to register at the Web site for planning purposes. The Government anticipates that registered presenters will be allotted 20 minutes each for presentations (limit of one speaker per organization); however, the Government retains the right to limit the number of presentations and/ or limit the allotted time for presentations based upon the number of registered presenters. Presenters will be notified about the scheduled order of presentations and the list of presenters will be posted on the meeting Web site at least one week prior to the meeting. It is anticipated that the meeting will include time for questions and information exchange. The slides from the presentations may appear in internal reports or be made public. Further information will be made available on the meeting Web site. Persons needing interpreting services in order to attend should contact 301-402-8180 (voice) or 301- 435-1908 (TTY). For other special accommodations while on NIEHS campus, contact 919-541-2475 or e-mail niehsoeeo@niehs.nih.gov.

This notice is to inform the public that the Office of Population Affairs (OPA) is awarding, in fiscal year 2008, $50,000 to the University of Northern Colorado, under Title X of the PHS Act (42 U.S.C. 300, et seq.). This institution proposes to conduct research activities, authorized under section 1004 of the Act, which are relevant to the purposes of the statue. These purposes include research in the behavioral and program implementation fields related to family planning and population. The Title X research program is described in the Catalog of Federal Domestic Assistance Number 93.974.

This proposed rule would address proposed changes to Medicare Part B payment policy. We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This proposed rule also discusses refinements to resource-based practice expense (PE) relative value units (RVUs); geographic practice cost indices (GPCI) changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); application of health professional shortage area (HPSA) bonus payments; payment for renal dialysis services; performance standards for mobile independent diagnostic testing facilities; and physician and nonphysician practitioners furnishing diagnostic testing services; a solicitation for comments regarding the use of the Federal Payment Levy Program to recover delinquent Federal tax debts; a proposed amendment to the exemption for computer-generated facsimile transmissions from the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for transmitting prescription and certain prescription-related information for Part D covered drugs prescribed for Part D eligible individuals; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); revisions for rehabilitation agencies; therapy-related technical corrections; the physician quality reporting initiative; physician self-referral issues and anti-markup; beneficiary signature for nonemergency ambulance transport; the chiropractic services demonstration; educational requirements for nurse practitioners and clinical nurse specialists; qualifications of portable x-ray supplier personnel; the expiration of provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007; bonus payments for long ambulance transports; the annual update for clinical laboratory fees under the clinical laboratory fee schedule; physician certification/recertification for home health services; a prohibition concerning providers of sleep tests; organ retrieval; a revision to the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges'' final rule; and, potentially misvalued services under the physician fee schedule.

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

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following public meeting to discuss current respirator standards development projects for Closed-Circuit Self-Contained Breathing Apparatus; Supplied Air Respirators; Reevaluation of NIOSH Limitations on and Precaution for Safe Use of Positive-Pressure Closed-Circuit Self-Contained Breathing Apparatus; and the Mechanical Connector Design Used in the Chemical Biological Radiological and Nuclear (CBRN) Air-Purifying Respirator (APR).

The Food and Drug Administration (FDA) is seeking volunteers from pharmaceutical companies to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, consistent with the principles of quality by design and risk management in pharmaceutical manufacturing. The purpose of the pilot program is to gain more information on and facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. This pilot will focus on products reviewed by FDA's Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER). This pilot program will assist FDA in developing guidance for industry on quality by design and risk management in pharmaceutical manufacturing. The pilot is open to original submissions of and supplements to biologic license applications (BLA) or new drug applications (NDA) reviewed by OBP.

Under the provisions of Section 3507(a)(l)(D) of the Paperwork Reduction Act of 1995 for the opportunity for public comment on the proposed data collection projects, the Center for Scientific Review (CSR), National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The purpose of this notice is to allow 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. PROPOSED COLLECTION: Title: Reinstatement of Generic Clearance for Voluntary Partner and Customer Satisfaction Surveys. Type of Information Collection Request: Reinstatement. Need and Use of Information Collection: The information collected in these surveys will be used by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair, unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys will almost certainly lead to quality improvement activities to enhance and/or streamline CSR's operations. The major mechanism by which CSR will request input is through surveys. The major initiatives ongoing at the present time include: shortening the review and application process, shortening the grant application, recruiting the best reviewers by developing additional review modes, improving study section alignment to ensure the best reviews, and others. Surveys will be collected via Internet. Information gathered from these surveys will be presented to, and used directly by, CSR management to enhance the operations, processes, organization of, and services provided by the Center. Frequency of Response: The participants will respond once, unless there is a compelling reason for a subsequent survey. Affected public: Universities, not-for-profit institutions, business or other for-profit, small businesses and organizations, and individuals. Type of Respondents: Adult scientific professionals.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below 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 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 that a collection of information entitled ``Request for Designation as Country not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) facility, Parks Township, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Hanford Nuclear Reservation in Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC: All employees of the Department of Energy (DOE), its predecessor agencies, and DOE contractors or subcontractors who worked from: 1. September 1, 1946 through December 31, 1961 in the 300 area; or 2. January 1, 1949 through December 31, 1968 in the 200 areas (East and West) at the Hanford Nuclear Reservation in Richland, Washington, for a number of work days aggregating at least 250 work days occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. This designation will become effective on June 29, 2008, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Kellex/Pierpont facility in Jersey City, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of the information technology (IT) Plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan'' to achieve the objectives defined in the PDUFA Performance Goals. This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the review process of human drug applications.

This proposed notice acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

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.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee'') will be held on Wednesday, August 20, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the oncologic indications of 2-[F-18] Fluoro-D-Glucose (FDG) positron emission tomography (PET) for nine cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney). The panel will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The panel will also consider data generated under a current national coverage determination that provides coverage for PET for specified cancers when additional data are prospectively collected. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This general notice with comment period describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FIs) and carriers in the administration of the Medicare program. The results of these evaluations are considered whenever we enter into, renew, or terminate a FI agreement, carrier contract, or take other contract actions, for example, assigning or reassigning providers or services to a FI or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.

This final rule implements a number of regulatory provisions that are applicable to all providers and suppliers, including durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. This final rule establishes appeals processes for all providers and suppliers whose enrollment, reenrollment or revalidation application for Medicare billing privileges is denied and whose Medicare billing privileges are revoked. It also establishes timeframes for deciding enrollment appeals by an Administrative Law Judge (ALJ) within the Department of Health and Human Services (DHHS) or the Departmental Appeals Board (DAB), or Board, within the DHHS; and processing timeframes for CMS' Medicare fee-for-service (FFS) contractors. In addition, this final rule allows Medicare FFS contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. This final rule also specifies that a Medicare contractor may establish a Medicare enrollment bar for any provider or supplier whose billing privileges have been revoked. Lastly, the final rule requires that all providers and suppliers receive Medicare payments by electronic funds transfer (EFT) if the provider or supplier, is submitting an initial enrollment application to Medicare, changing their enrollment information, revalidating or re- enrolling in the Medicare program.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2009.

This proposed rule would establish location requirements including exception criteria for rural health clinics (RHCs). It would also require RHCs to establish a quality assessment and performance improvement (QAPI) program. In addition, it would: Clarify our policies on ``commingling'' of an RHC with another entity; revise the RHC and Federally Qualified Health Centers (FQHC) payment methodology and exceptions to the per-visit payment limit to implement statutory requirements; revise RHC and FQHC payment requirements for services furnished to skilled nursing facility (SNF) patients; allow RHCs to contract with RHC nonphysician providers under certain circumstances; and update the regulations pertaining to waivers to the staffing requirements. This proposed rule would also add requirements for RHCs and FQHCs to maintain and document an infection control process and to post RHC or FQHC hours of clinical services. In addition, this proposed rule would update the requirements under the emergency services standard and patient health records condition for certification (CfC) to reflect advancements in technology and treatment. Finally, this proposed rule solicits comments on payment for high cost drugs and the appropriateness of a mental health specialty clinic as an exception to the location requirements.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2008 through March 2008, 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. Included in this notice is 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. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. 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.