The Federal Register

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Jun 27 2008 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6395960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

Restriction on Travel of Persons (OMB Control No. 09200488) Reinstatement without ChangeNational Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention is requesting OMB approval to reinstate without change the information collection request, Rest

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Elimination of Health

Fri, Jun 27 2008 11:00:00 GMT

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 10 a.m.5 p.m., July 16, 2008 (Closed).

Place: Teleconference.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ``Elimination of Health Disparities through Translation Research (Panel C), FOA CD08001.''

Contact Person for More Information: Susan B. Stanton, D.D.S., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone (404) 6394640.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Regis

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Elimination of Health

Fri, Jun 27 2008 11:00:00 GMT

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 10 a.m.5 p.m., July 15, 2008 (Closed).

Place: Teleconference.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ``Elimination of Health Disparities through Translation Research (Panel B), FOA CD08001.''

Contact Person for More Information: Susan B. Stanton, D.D.S., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone (404) 6394640.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Regi

Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services

Fri, Jun 27 2008 11:00:00 GMT

This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusionrelated data to 10 years. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.

Medicare Program; Appeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the

Fri, Jun 27 2008 11:00:00 GMT

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 feeforservice (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

Medicare Program; Special Enrollment Period and Medicare Premium Changes

Fri, Jun 27 2008 11:00:00 GMT

This final rule provides a special enrollment period (SEP) for Medicare Part B and premium Part A for certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and who have health insurance that covers them while outside the United States. Under the SEP provision, qualifying volunteers can delay enrollment in Part B and premium Part A, or terminate such coverage, for the period of service outside of the United States and reenroll without incurring a premium surcharge for late enrollment or reenrollment.

This final rule also codifies provisions that require certain beneficiaries to pay an incomerelated monthly adjustment amount (IRMAA) in addition to the standard Medicare Part B premium, plus any applicable increase for late enrollment or reenrollment. The income related monthly adjustment amount is to be paid by beneficiaries who have a modified adjusted gross income that exceeds certain threshold amounts. It also represents the amount of de

Medicare Program; Use of Repayment Plans

Fri, Jun 27 2008 11:00:00 GMT

This final rule modifies Medicare regulations to implement section 935(a) 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'') for Medicare provider and supplier overpayments. Under this provision, we are granting a provider or a supplier an ERS under certain terms and conditions as defined in the statute. This final rule establishes criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.''

Medicare Program; Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics

Fri, Jun 27 2008 11:00:00 GMT

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 pervisit 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 ser

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--January Through March 2008

Fri, Jun 27 2008 11:00:00 GMT

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 Medicareapproved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coveragerelated guidance documents, and special onetime notices regarding national coverage provis

Medicare and Medicaid Programs; The Joint Commission for Continued Deeming Authority for Ambulatory Surgical Centers

Fri, Jun 27 2008 11:00:00 GMT

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
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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 30day public comment period.

Medicare and Medicaid Programs; Application by the Accreditation Association for Ambulatory Health Care for Continued

Fri, Jun 27 2008 11:00:00 GMT

This proposed notice acknowledges the receipt of a deeming application from the Accreditation Association for Ambulatory Health Care (AAAHC) 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 30day public comment period.

Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance During Fiscal Year 2009

Fri, Jun 27 2008 11:00:00 GMT

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.

Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification

Fri, Jun 27 2008 11:00:00 GMT

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second semiannual 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.

Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee--August 20, 2008

Fri, Jun 27 2008 11:00:00 GMT

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[F18] FluoroDGlucose (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 patientcentered 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 vari

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Jun 27 2008 11:00:00 GMT

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.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New

Fri, Jun 27 2008 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Jun 27 2008 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Jun 27 2008 11:00:00 GMT

Center for Scientific Review; Notice of Closed Meetings

Fri, Jun 27 2008 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Core Instrumentation.

Date: July 1415, 2008.

Time: 8 a.m. to 4:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

Contact Person: Joseph D. Mosca, PhD, Scientific Review Officer, Cen

National Institute on Drug Abuse; Notice of Closed Meeting

Fri, Jun 27 2008 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Conference Grant Review Committee.

Date: July 18, 2008.

Time: 1 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

Contact Person: Mark R. Green, PhD, Deputy Director, O

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Jun 27 2008 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: 2009 National Survey on Drug Use and Health(OMB No. 0930 0110)Revision

The National Survey on Drug Use and Health (NSDUH), formerly the National Household Survey on Drug Abuse (NHSDA) is a survey of the civilian, noninstitutionalized population of the United States 12 years old and older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, ONDCP, Federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources.

In the 2009 NSDUH, one scale measuring im