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Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; Availability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 The draft guidance document is intended to provide recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic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 The draft guidance is intended to provide assistance by identifying the types of data and information obtained during investigational new drug studies that may be helpful in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.
Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Moratorium on the Establishment of New Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities and Increases in Beds in Existing Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities; and 3-Year Delay in the Application of Certain Payment Adjustments
This interim final rule with comment period implements certain provisions of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long-term care hospitals (LTCHs) and LTCH satellite facilities. It implements a 3-year moratorium on the establishment of new LTCHs and LTCH satellite facilities; and on increases in beds in existing LTCHs and LTCH satellite facilities. This interim final rule with comment period also implements a 3-year delay in the application of certain payment policies which apply payment adjustments for discharges from LTCHs and LTCH satellites that were admitted from certain referring hospitals in excess of various percentage thresholds.