The Federal Register

2005 White House Conference on Aging

Tue, Nov 22 2005 11:00:00 GMT

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging (WHCoA) will have a conference call to finalize the resolutions and other items related to the 2005 WHCoA. The conference call will be open to the public to listen, with callins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.

Statement of Organization, Functions, and Delegations of Authority

Tue, Nov 22 2005 11:00:00 GMT

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 F 6777276, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 70 FR 6590165902, dated November 1, 2005) is amended to reorganize the Pittsburgh Research Laboratory, National Institute for Occupational Safety and Health.

Section CB, Organization and Functions, is hereby amended as follows:

After the title for the Pittsburgh Research Laboratory (CCB), delete the functional statement and insert the following:

Pittsburgh Research Laboratory (CCB). (1) Provides national and international leadership for prevention of workrelated illness, injury, and fatalities of mine workers; (2) carries out the surveillance of fatal and nonfatal traumatic injuries, occupational diseases, health and safety hazards, and the use of control technology and protective equipment for pr

Medicare Program; Hospice Care Amendments

Tue, Nov 22 2005 11:00:00 GMT

This final rule revises existing regulations that govern coverage and payment for hospice care under the Medicare program. These revisions reflect the statutory changes required by the Balanced Budget Act of 1997 (BBA), the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). Additionally, these revisions reflect current policy on the documentation needed to support a certification of terminal illness, admission to Medicare hospice, and a new requirement that allows for discharges from hospice for cause under very limited circumstances.

This final rule does not address the requirement for hospice data collection, the changes to the limitation of liability rules, or the changes to the hospice conditions of participation that were included in the BBA.

The intent of this final rule is to expand the hospice benefit periods, improve documentation requirements to support certif

Submission for OMB Review; Comment Request

Tue, Nov 22 2005 11:00:00 GMT

Title: Developmental Disabilities State Plan.

OMB No.: 09800162.

Description: A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a fiveyear basis. On an annual basis, the Council must review the plan and make any amendments. The State Plan will be used (1) by the Council as a planning document; (2) by the citizenry of the State as a mechanism for commenting on the plans of the Council; and (3) by the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act, as one basis for providing technical assistance (e.g., during site visits), and as a support for management decision making.

Respondents: State and Tribal Govenments.
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Proposed Information Collection Activity; Comment Request

Tue, Nov 22 2005 11:00:00 GMT

Proposed Projects

Title: April 2006 Current Population Survey Supplement on Child Support.

OMB No. 09920003.

Description: Collection of these data will assist legislators and policymakers in determing how effective their policymaking efforts have been over time in applying the various child support legislation to the overall child support enforcement picture. This information will help policymakers determine to what extent individuals on welfare would be removed from the welfare rolls as a result of more stringent child support enforcement efforts.

Respondents: Individuals and Households.
Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours Child Support Survey.

Submission for OMB Review; Comment Request

Tue, Nov 22 2005 11:00:00 GMT

Title: Form ACFIVE1: Title VIE Foster Care and Adoption Assistance Financial Report.

OMB No.: 09700205.

Description: State agencies administer the Foster Care and Adoption Assistance Programs under Title IVE of the Social Security Act. The Administration for Children and Families (ACF) provides Federal funding at the rate of 50 percent for most administrative and other related costs and at an enhanced rate of 75 percent for training costs as detailed in Federal statute and regulations. This form is submitted quarterly by each State to estimate the funding needs for the upcoming fiscal quarter and to
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report expenditures for the fiscal quarter just ended. This form is also used to provide annual budget projections from each State. The information collected in this report is used by this agency to calculate quarterly Federal grant awards and to enable this agency to submit budget requests to Congress through the Department and to enable oversight of the financial manageme

Submission for OMB Review; Comment Request

Tue, Nov 22 2005 11:00:00 GMT

Title: State High Performance Bonus System (HPBS) Transmission File Layouts for HPBS Work Measures.

OMB No.: 09700230.

Description: This is a proposed reinstatement of a previously approved information collection. The purpose of this collection is to obtain data upon which to base the computation for measuring State performance in meeting the legislative goals of TANF as specified in section 403(a)(4) of the Social Security Act and 45 CFR part 270. Specifically, the Department of Health and Human Services (HHS) will use the data to award the portion of the bonus that rewards States for their success in moving TANF recipients from welfare to work. States will not be required to submit this information unless they elect to compete on a work measure for the TANF High Performance Bonus awards.

Respondents: Respondents may include any of the 50 States, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands. Annual Burden Estimate

Invitation to Comment on Proposed Data Composites and Potential Performance Areas and Measures for the Child and

Tue, Nov 22 2005 11:00:00 GMT

Corrective Action: The initial publication in the Federal Register on November 7, 2005 (70 FR 67479) inadvertently omitted the date that the comments are due to the Children's Bureau. The due date for comments is December 7, 2005.

Dated: November 17, 2005.
Reginia H. Ryan,
Director, Executive Secretariat, ACYF.
[FR Doc. 0523206 Filed 112105; 8:45 am]
BILLING CODE 418401P

Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records

Tue, Nov 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Questions and Answers Regarding Establishment and Maintenance of Records (Edition 2).'' The guidance responds to various questions raised about section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation must be in compliance by December 9, 2005, June 9, 2006, or December 11, 2006, depending on the size of the business.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for

Tue, Nov 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Requesting an Extension

Tue, Nov 22 2005 11:00:00 GMT

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 the proposed collection of information associated with the guidance document entitled ``Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.'' Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the Office of Management and Budget (OMB's) approval of this collection of information (OMB control number 09100571). Since this was an emergency approval that expires on January 1, 2006, FDA is following the no

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for

Tue, Nov 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing an opportunity for public comment on this collection of information. Since this collection received emergency approval that expires on January 1, 2006, FDA is following the normal PRA clearance procedures by issuing that notice.

HIPAA Administrative Simplification: Standards for Electronic Health Care Claims Attachments; Extension of Comment

Tue, Nov 22 2005 11:00:00 GMT

This notice extends the comment period for a proposed rule published in the Federal Register on September 23, 2005 (70 FR 55990) that would recommend the adoption of a set of standards to facilitate the electronic exchange of clinical and administrative data to further improve the claims adjudication process when additional documentation is required. Due to the very technical nature of this rule, the industry is asking for additional time to conduct a more comprehensive and thorough review in order to provide comments to the Standards Development Organizations as well as to CMS. The comment period is extended for 60 days.

Advisory Commission on Childhood Vaccines; Notice of Meeting

Tue, Nov 22 2005 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), notice is hereby given of the following meeting:

Name: Advisory Commission on Childhood Vaccines (ACCV).

Date and Time: December 12, 2005, 9 a.m.5 p.m., EST.

Place: Audio Conference Call and Parklawn Building, Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.

The ACCV will meet on Monday, December 12, from 9 a.m. to 5 p.m. The public can join the meeting in person at the address listed above or by audio conference call by dialing 18003696048 on December 12 and providing the following information:

Leader's Name: Dr. Geoffrey Evans.

Password: ACCV.

Agenda: The agenda items for the December meeting will include, but are not limited to: A summary of the U.S. Court of Federal Claims' 18th Judicial Conference; a report from the ACCV Workgroup looking at proposed guidelines for future changes to the Vaccine Injury Table; and updates from the Division of Vaccine Injury C

Publication of OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees

Tue, Nov 22 2005 11:00:00 GMT

OIG periodically develops and issues guidance, including Special Advisory Bulletins, to alert and inform the health care industry about potential problems or areas of special interest. This Federal Register notice sets forth the recently issued OIG Special Advisory Bulletin addressing patient assistance programs for Medicare Part D enrollees.