Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 26th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 27th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 24th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 27th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
This notice announces the 20th meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 18th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Department of Health and Human Services Implementation of New Authorities for the Public Health Emergency Preparedness Cooperative Agreement
The Department of Health and Human Services (HHS or the Department), Centers for Disease Control and Prevention (CDC), will issue an Interim Progress Report (IPR) for the PHEP cooperative agreement program in the third quarter of Fiscal Year (FY) 2008, as authorized under section 319C-1 of the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) (Pub. L. 109-417) (42 U.S.C. 247d-3a). The Consolidated Appropriations Act, 2008, (H.R. 2764) provided funding for these awards. This notice provides information to facilitate the critical aspects of the program, including: Background of the program; Current requirements for awardees: [cir] MOF; Future requirements of awardees: [cir] Nonfederal matching requirementsreduced or no award provided; [cir] Evidence-based benchmarks and objective standards substantial failure results in withholding of funds; [cir] Maximum amount of carryoverexceeding the limit results in repayment of funds; [cir] Pandemic influenza planning documentsfailure to submit a sufficient operations plan results in withholding of funds; [cir] Audit requirementsfailure results in repayment of funds; Electronic submission; Important dates; Reporting; PHEP IPR for BP9 (http://www.emergency.cdc.gov/); Withholding and Repayment Guidance (Attachment).
Government-Owned Inventions; Availability for Licensing
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.
Reportable Food Registry as Required by the Food and Drug Administration Amendments Act of 2007; Announcement of Delay in Implementation and Request for Comments
The Food and Drug Administration (FDA) is announcing a delay in the implementation of the Reportable Food Registry (the Registry) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA intends to implement the FDAAA requirement to establish an electronic portal for reportable food by utilizing the business enterprise system currently under development by the agency. This system will be easy to use and the most efficient and cost effective for both users and the agency. FDA expects that the agency's business enterprise system will be operational in spring 2009. FDA acknowledges that the prohibited act provisions relating to the Registry will not apply until such time as FDA establishes the electronic portal to implement the Registry. In conjunction with this delay announcement, FDA is requesting comments on certain aspects of the Registry provisions.
State Children's Health Insurance Program (SCHIP); Retrospective Adjustment for Additional Allotments To Eliminate Fiscal Year (FY) 2007 Funding Shortfalls; Final SCHIP Allotments for FYs 2008 and 2009; Redistribution of Unused SCHIP FY 2005 Allotments To Eliminate FY 2008 Funding Shortfalls; Additional Allotments To Eliminate FY 2008 Funding Shortfalls; and Provisions for Continued Authority for Qualifying States To Use a Portion of Certain SCHIP Funds for Medicaid Expenditures
This notice describes the implementation of certain funding provisions under title XXI of the Social Security Act (SCHIP) as amended by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), (Pub. L. 110-173), and other related SCHIP legislation. These funding provisions include: The retrospective adjustment of the additional allotments to eliminate fiscal year (FY) 2007 SCHIP funding shortfalls; the final FYs 2008 and 2009 SCHIP allotments; the redistribution of the amounts of States' unused FY 2005 allotments to eliminate FY 2008 SCHIP funding shortfalls; the provision of additional allotments to eliminate FY 2008 SCHIP funding shortfalls; and the provision for ``qualifying States'' to elect to use a portion of their available SCHIP allotments as increased Federal matching funds for certain expenditures in their Medicaid programs under title XIX of the Act.
Office of the Assistant Secretary for Planning and Evaluation; State Long-Term Care Partnership Program: Reporting Requirements for Insurers
This proposed rule sets forth proposed reporting requirements for private insurers that issue qualified long-term care insurance policies in States participating in the State Long-Term Care Partnership Program established under the Deficit Reduction Act (DRA) of 2005. Section 6021 of the Deficit Reduction Act of 2005 requires that the Secretary specify a set of reporting requirements and collect data from insurers on qualifying long-term care insurance policies issued under the program and the subsequent use of the benefits under these policies. Under a State Long-Term Care Partnership Program, an amount equal to the benefits received under of the long-term care insurance policy is disregarded in determining the assets of an individual for purposes of Medicaid eligibility and estate recovery.
Medicare Program; Provider Reimbursement Determinations and Appeals
Subpart R of 42 CFR part 405 consists of regulations governing Medicare reimbursement determinations, and appeals of those determinations, by health care providers. (For the sake of simplicity, throughout this final rule, we use ``reimbursement'' to refer to Medicare payment under both the reasonable cost and prospective payment systems.) Under section 1878 of the Social Security Act (the Act) and the subpart R regulations, the Provider Reimbursement Review Board (the Board) has the authority to adjudicate certain substantial reimbursement disputes between providers and fiscal intermediaries (intermediaries). Board decisions are subject to review by the CMS Administrator, and the final agency decision of the Board or the Administrator, as applicable, is reviewable in Federal district court. In addition, under the subpart R regulations, intermediaries have the authority to hold hearings and adjudicate certain other payment and reimbursement disputes with providers. This final rule updates, clarifies, and revises various provisions of the regulations governing provider reimbursement determinations, appeals before the Board, appeals before the intermediaries (for lesser disputes), and Administrator review of decisions made by the Board.
Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education, June 26, 2008
In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Medicare and Medicaid Programs; The Joint Commission for Continued Deeming Authority for Critical Access Hospitals
This proposed notice with comment period acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals (CAHs) 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.
Medicare, Medicaid, and CLIA Programs; Continuing Approval of AABB (Formerly the American Association of Blood Banks as a CLIA Accreditation Organization
In this notice, we reapprove and grant AABB (formerly known as the American Association of Blood Banks) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) accreditation program and the Immunohematology Reference Laboratory (IRL) Program.
Memorandum of Understanding With the U.S. Army Corps of Engineers, Mobile District
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the U.S. Army Corps of Engineers, Mobile District. This MOU establishes a mutual framework governing the respective responsibilities of the parties for the provision of health services through the Corps' Regional Occupational Health Center to FDA employees at the FDA Gulf Coast Seafood Laboratory. Goods and services the Corps may provide include, but are not limited to, physicals at age-appropriate intervals, referral of employees to private physicians, prevention programs related to health, and other related goods and services as meet the criteria and standards of the Public Health Service, immunizations for influenza and tetanus, and safety and environmental counseling
Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products'' dated May 2008. The draft guidance document is intended to provide recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus. The draft guidance is intended to provide assistance by identifying the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA).
Implantation or Injectable Dosage Form New Animal Drugs; Cefovecin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of a solution of cefovecin sodium in cats and dogs by subcutaneous injection for the treatment of skin infections.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of food industry supervisory employees about their awareness and perceptions of FDA's Food Defense Awareness Initiative ALERT.
Office of Refugee Resettlement; Grant Notice
Notice is hereby given that the Office of Resettlement, Division of Community Resettlement, will award supplemental funds without competition to nine agencies: Church World Service, Ethiopian Community Development Council, Episcopal Migration Ministries, Hebrew Immigrant Aid Society, International Rescue Committee, Lutheran Immigration and Refugee Services, the United States Committee for Refugees and Immigrants, the United States Conference of Catholic Bishops, and World Relief Corporation. The cost for these supplemental awards is $2.17 million. The Voluntary Agency Matching Grant program was created by Congress in 1979. Matching Grant services enable the Voluntary Agencies' resettlement agencies to work with recently arrived refugees and other eligible clients. The goal of the program is to assist refugees become economically self-sufficient without accessing public assistance within 120-180 days. Last year, 81% of clients entering the program were economically self-sufficient within 180 days. Since the Presidential Determination was signed in October 2007, the ceiling for refugees was raised from 70,000 to 80,000 to accommodate 10,000 additional Iraqi refugees. In addition, legislation passed in December 2007 and January 2008 created a new class of individuals eligible for the refugee services. Thousands of Afghani and Iraqi interpreters who served the U.S. military have been provided ``Special Immigrant Visas'' (SIV) and are now eligible for six or eight months of refugee services. The Matching Grant program is often the program of choice for these special populations as it is geared for readily employable cases and for SIV cases, conforms to the legislative time limits.