Department of Health and Human Services March 23, 2011 – Federal Register Recent Federal Regulation Documents
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Memorandum of Agreement Between the Indian Health Service and the Department of Interior; Bureau of Indian Affairs and Bureau of Indian Education
The Indian Health Service (IHS) is providing notice of a Memorandum of Agreement (MOA) between the IHS and the Department of the Interior (DOI), signed in 2009, and has developed an amendment to that MOA that includes language consistent with Section 703 of the Indian Health Care Improvement Act (IHCIA), Public Law 94-437, as amended. The purpose of the MOA and the amendment is to advance our partnership with Tribes and Federal stakeholders on alcohol and substance abuse prevention and treatment. The Patient Protection and Affordable Care Act's, Public Law 111-148, permanent authorization of the Indian Health Care Improvement Act (IHCIA) establishes timelines and requirements for coordinated actions by the Department of Interior (DOI), the Department of Health and Human Services (HHS), Tribes and Tribal organizations. Specifically, Section 703 of the IHCIA provides new authorities that permit the DOI and HHS, acting through the Indian Health Service (IHS), to develop and enter into a Memorandum of Agreement (MOA), or review and update any existing memoranda of agreement, as required by Section 4205 of the Indian Alcohol and Substance Abuse Prevention and Treatment Act of 1986 (25 U.S.C.2411). DOI and IHS signed an MOA on this topic in 2009, and have developed an amendment to that MOA that includes language consistent with the new IHCIA provision. In accordance with Section 703 of the IHCIA, which states that the MOA between the IHS and DOI shall be published in the Federal Register, the agency is publishing notice of this MOA and the amendment to this MOA.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for 2011
This notice announces the $505 calendar year (CY) 2011 application fee for institutional providers that are: Initially enrolling in the Medicare, program; revalidating their Medicare enrollment; or adding a new Medicare practice location. These institutional providers and suppliers are required to submit the 2011 fee amount with any enrollment applications submitted on or after March 25, 2011 and on or before December 31, 2011. Similarly, beginning March 25, 2011 prospective or re-enrolling Medicaid or CHIP providers must submit the applicable application fee unless: (1) The provider is an individual physician or nonphysician practitioner; or (2) the provider is enrolled in Title XVIII of the Act or another State's title XIX or XXI plan and has paid the application fee to a Medicare contractor or another State.
Tolerances for Residues of New Animal Drugs in Food; 2-Acetylamino-5-Nitrothiazole; Buquinolate; Chlorobutanol; Estradiol and Related Esters; Ethylenediamine; Florfenicol; Flunixin; Furazolidone; Hydrocortisone; Methylparaben; Methylprednisolone; Prednisolone; Prednisone; Progesterone; Propylparaben; and Salicylic Acid
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the revocation of tolerances for residues of various substances in food because approval has been withdrawn for the underlying food additive petitions (FAPs) or new animal drug applications (NADAs). This action is being taken to improve the accuracy of the regulations.
Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This revised draft guidance replaces the original draft guidance published in the Federal Register of June 9, 2010 (75 FR 32791). The original draft guidance was revised to remove potential ambiguities and to address several issues not included in the original draft guidance. This revised draft guidance is intended to help small entities comply with the final rule entitled ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.''
Draft Guidance for Industry: Testing for Salmonella
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods.'' The draft guidance, when finalized, is intended for firms that manufacture, process, pack, or hold human foods or direct-human-contact animal foods intended for distribution to consumers, institutions, or food processors. The draft guidance does not apply to egg producers and other persons who are covered by FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The draft guidance addresses testing procedures for Salmonella species (spp.) in human foods (except shell eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence of Salmonella spp. in the food may render the food injurious to human health.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Bacteriophage Preparation
The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations to provide for the use of a bacteriophage preparation as an antimicrobial agent against Listeria monocytogenes on ready-to-eat (RTE) meat and poultry products. After reviewing the objections to the final rule and the requests for a hearing, the Agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulation. FDA also is denying the request for a stay of the effective date of the final rule.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability
The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance entitled ``Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' This guidance document describes a means by which the ovarian adnexal mass assessment score test system may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for the ovarian adnexal mass assessment score test system, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
The Food and Drug Administration (FDA) is proposing to amend the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery. Elsewhere in this issue of the Federal Register, FDA is announcing a final rule that classifies the ovarian adnexal mass assessment score test system into class II (special controls).
Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System
The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.
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