Department of Health and Human Services November 25, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Phoenix Scientific, Inc., to IVX Animal Health, Inc. In order to improve the accuracy of the regulations, erroneous entries for Phoenix Pharmaceutical, Inc., are also being removed at this time.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Schering- Plough Animal Health Corp.
Implantation or Injectable Dosage Form New Animal Drugs; Boldenone
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 Fort Dodge Animal Health. The supplemental NADA provides for revised labeling for the veterinary prescription use of injectable boldenone solution in horses.
New Animal Drugs; Flunixin
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 Schering-Plough Animal Health Corp. The supplemental NADA provides for the veterinary prescription use of flunixin meglumine solution by intramuscular injection for the control of pyrexia associated with swine respiratory disease.
Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
The Food and Drug Administration (FDA) is proposing to amend its food labeling regulations for the expanded use of the nutrient content claim ``lean'' on the labels of foods categorized as ``mixed dishes not measurable with a cup'' that meet certain criteria for total fat, saturated fat, and cholesterol content. This proposal responds to a nutrient content claim petition submitted by Nestl[eacute] Prepared Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic Act (the act). This action also is being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2005 Rates: Fire Safety Requirements for Religious Non-Medical Health Care Institutions: Correction To Reinstate Requirements for Written Fire Control Plans and Maintenance of Documentation
In the August 11, 2004 issue of the Federal Register (69 FR 48916), we published the Hospital Inpatient Prospective Payment System final rule. This correcting amendment reinstates paragraphs (a)(2) and (a)(3) in 42 CFR 403.744 (Condition of participation: Life safety from fire), which were accidentally deleted by that rule. Those paragraphs relate to requirements for fire control plans and maintenance of documentation in religious non-medical health care institutions. The effective date was October 1, 2004.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
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 focus groups as used by FDA to gauge public opinion. Policymakers can use focus group results to test and refine their ideas so they can conduct further research, as well as, adopt new policies and to allocate or redirect significant resources to support these policies.
Medicare Program; Coverage and Payment of Ambulance Services; Inflation Update for CY 2006
This notice announces an updated Ambulance Inflation Factor (AIF) for payment of ambulance services during calendar year (CY) 2006. The statute requires that this inflation factor be applied in determining the fee schedule amounts and payment limits for ambulance services. The updated AIF for 2006 applies to ambulance services furnished during the period January 1, 2006, through December 31, 2006.
Medicare Program; Electronic Submission of Medicare Claims
This final rule adopts as final, and makes amendments to, the interim final rule published on August 15, 2003. That interim final rule implemented the statutory requirement that claims for reimbursement under the Medicare Program be submitted electronically as of October 16, 2003, except where waived. These regulations identify those circumstances for which mandatory submission of electronic claims to the Medicare Program is waived.
Federal Enforcement in Group and Individual Health Insurance Markets
This rule makes final an interim final rule that details procedures we use for enforcing title XXVII of the Public Health Service Act as added by the Health Insurance Portability and Accountability Act of 1996, and as amended by the Mental Health Parity Act of 1996, the Newborns' and Mothers' Health Protection Act of 1996, and the Women's Health and Cancer Rights Act of 1998. Specifically, we are responsible for enforcing title XXVII requirements in States that do not enact the legislation necessary to enforce those requirements, or otherwise fail to substantially enforce the requirements. We are also responsible for taking enforcement actions against non-Federal governmental plans. The regulation describes the process we use in both enforcement contexts. This final rule deletes an appendix to the interim rule that listed examples of violations of title XXVII and corrects the description of a cross-reference, but makes no substantive changes to the interim final rule.
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