The Federal Register

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Nov 27 2007 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/ATSDR Reports Clearance Officer at (404) 6395960 or send an e mail to omb@cdc.gov. Send
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written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (303) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project

Select Agent Distribution Activity: Request for Select Agent (OMB Control No. 09200591)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 a three year extension to continu

Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates, the

Tue, Nov 27 2007 11:00:00 GMT

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. We describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2008. In addition, the rule sets forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system apply, and other pertinent rate setting information for the CY 2008 ASC payment system. Furthermore, this final rule with comment period will make changes to the policies relating to the necessary provider designations of critical access hospitals and changes to several of the current conditions of participation requirements.

The attached

and 485

Tue, Nov 27 2007 11:00:00 GMT

This final rule with comment period addresses certain provisions of the Tax Relief and Health Care Act of 2006, as well as making other proposed changes to Medicare Part B payment policy. We are making these changes 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 refinements to resourcebased 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 including additional codes from the 5Year Review; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); clinical lab fee schedule issues; payment for renal dialysis services; performance standards for independent diagnostic testing facilities; expiration of the physician scarcity area (PSA) bonus payment; conforming and clarifying changes for com

Submission for OMB Review; Comment Request

Tue, Nov 27 2007 11:00:00 GMT

Title: Assets for Independence Program Performance Management and Report to Congress Data Collection Form.

OMB No.: New Collection.

Description: The Assets for Independence (AFI) program is a program authorized by Section 403 of the Community Opportunities,
Accountability, and Training and Educational Services Act of 1998 (the Act). The Office of Community Services (OCS) within the U.S. Department of Health and Human Services (HHS) administers the AFI program to support innovative assetbuilding projects that feature Individual Development Accounts (IDAs), financial education, and related services. The Act requires AFI program grantees to submit annual reports to OCS with detailed information about project operations and participant activities. The information collected is issued by OCS for performance management and to prepare mandated Reports to Congress.

The AFI Program Performance Management and Report to Congress Data Collection Form is used to collect eight categories of info

Submission for OMB Review; Comment Request

Tue, Nov 27 2007 11:00:00 GMT

Title: Administrative Subpoena.

OMB No.: 09700152.

Description: Section 452(a)(11) of the Social Security Act requires the Secretary of the Department of Health and Human Services to promulgate a form for administrative subpoenas to be used in State child support enforcement programs to collect information for use in the establishment, modification and enforcement of child support orders in interstate cases. Section 454(9)(E) of the Social Security Act requires each State to cooperate with any other State in using the Federal form for issuance of administrative subpoenas in interstate child support cases. Tribal IVD agencies are not required to use this form but may choose to do so. OMB approval of this form is expiring in January 2008 and the administration for Children and Families is requesting an extension of this form.

Respondents: State, local or Tribal agencies administering a child support enforcement program under title IVD of the Social Security Act.

Submission for OMB Review; Comment Request

Tue, Nov 27 2007 11:00:00 GMT

Title: Voluntary Surveys of Program Partners to Implement Executive Order 12862.

OMB No.: 09800266.

Description: Under the provisions of the Federal Paperwork Reduction Act of 1995 (Pub. L. 10413), the Administration for Children and Families (ACFR) is requesting clearance for instruments to implement Executive Order 12862 within ACF. The purpose of the data collection is to obtain customer satisfaction information from those entities who are funded to be ACF's partners in the delivery of services to the American public. ACF partners are those entities that receive funding to deliver services or assistance from ACF programs. Examples of partners are State and local governments, Territories, service providers, Indian Tribes and Tribal organizations, grantees, researchers or other intermediaries serving target populations identified by and funded directly or indirectly by ACF. The surveys will obtain information about how well ACF is meeting the needs of its partners in operating the

Proposed Information Collection Activity; Comment Request

Tue, Nov 27 2007 11:00:00 GMT

Proposed Projects

Title: Required Data Elements for Voluntary Establishment of Paternity Affidavits.

OMB No.: 09700171.

Description: Section 466(a)(5)(C)(iv) of the Social Security Act (the Act) requires States to develop and use an affidavit for the voluntary acknowledgement of paternity. The affidavit for the voluntary acknowledgement of paternity must include the minimum requirements specified by the Secretary under section 452(a)(7) of the Act. The affidavits will be used by hospitals, birth record agencies, and other entities participating in the voluntary paternity establishment program.

Respondents: State and Tribal IVD agencies, hospitals, birth record agencies and other entities participating in the voluntary paternity establishment program.
Annual Burden Estimates Number of Average burden Instrument Number of respons

Proposed Information Collection Activity; Comment Request

Tue, Nov 27 2007 11:00:00 GMT

Proposed Project

Title: Descriptive Study of Early Head Start (DSEHS).

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), requests clearance to recruit Early Head Start (EHS) programs for participation in the Descriptive Study of Early Head Start (DSEHS) and to conduct a pilot test of potential measures.

DSEHS is a longitudinal study of a representative sample of programs and children in three age cohorts, which will collect information about programs, families, and services. When completed, data will be collected on a sample of approximately 2,100 children and families from 60 EHS programs. Data will be collected in four waves: Fall 2008, Fall 2009, Fall 2010, and Fall 2011. Children and families will be followed until children are three years old and exit EHS programs.

Data collected under DSEHS will complement information gathered under the Survey of Early Head Start Programs (SEHSP),

New Animal Drugs For Use in Animal Feeds; Fenbendazole

Tue, Nov 27 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds.

Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3

Tue, Nov 27 2007 11:00:00 GMT

The Food and Drug Administration (FDA) proposes to issue this rule finding that certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega3 fatty acids, do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) and may not appear in food labeling. This rule is being proposed in response to three notifications submitted to FDA under the act. One notification concerning nutrient content claims for alphalinolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and TransOcean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutriti

Behind the Counter Availability of Certain Drugs; Public Meeting; Comment Period Clarification

Tue, Nov 27 2007 11:00:00 GMT

In the Federal Register of October 4, 2007 (72 FR 56769), the Food and Drug Administration (FDA) published a notice that announced a public meeting to obtain comments regarding behindthecounter (BTC) availability of human drugs. An incorrect date was published in that notice. This document clarifies that Docket No. 2007N0356 will close on December 17, 2007.

National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy

Tue, Nov 27 2007 11:00:00 GMT

The Health Resources and Services Administration is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).

Pursuant to section 100.2 of the VICP's implementing regulations (42 CFR Part 100), the Secretary announces that the revised average cost of a health insurance policy under the VICP is $380.04 per month. In accordance with Sec. 100.2, the revised amount was effective upon its delivery by the Secretary to the United States Court of Federal Claims. Such notice was delivered to the Court on October 17, 2007.

Dated: November 19, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E723090 Filed 112607; 8:45 am]
BILLING CODE 416515P

HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements

Tue, Nov 27 2007 11:00:00 GMT

This notice solicits comments on the HRSA proposed uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for Fiscal Year 2008 and beyond. Title XXVI of the Public Health Service Act (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective Fiscal Year (FY) 2007. HRSA has issued guidance for obtaining a waiver for FY 2007 and seeks to issue waiver requirements for grantees under Parts A, B, and C of Title XXVI of the PHS Act for FY 2008 and future years.