Department of Health and Human Services March 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.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Nominations to the Advisory Committee on Blood Safety and Availability
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Irradiation in the Production, Processing, and Handling of Food; Confirmation of Effective Date
The Food and Drug Administration (FDA) is denying requests for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish. After reviewing objections to the final rule and requests for a hearing, FDA has concluded that the objections do not justify a hearing or otherwise provide a basis for revoking the regulation. FDA also is denying the request for a stay of the effective date of the amendment to the food additive regulations.
Hartech Corporation; Denial Without Prejudice of Food Additive Petition
The Food and Drug Administration (FDA) is denying a food additive petition (FAP 1M4246) proposing that the food additive regulations be amended to provide for the safe use of a source of ionizing radiation to treat shellfish, including crustaceans.
Alpha Omega Technology, Inc.; Denial Without Prejudice of Food Additive Petition
The Food and Drug Administration (FDA) is denying a food additive petition (FAP 0M4181) proposing that the food additive regulations be amended to provide for the safe use of a source of irradiation to treat shellfish and finfish.
Food and Drug Administration/Xavier University Global Medical Device Conference
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes presentations from key FDA officials and industry experts. The public conference has three separate tracks of interest for quality, regulatory affairs, and clinical research professionals, and is intended for companies of all sizes and employees at all levels. Dates and Times: The public conference will be held on May 4, 2011, from 8:30 a.m. to 5 p.m.; May 5, 2011, from 8:30 a.m. to 5 p.m.; and May 6, 2011, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 513-745-3396. Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, ext 167, FAX: 513-679-2772, e-mail: gina.brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 3 days of the conference. Early registration ends April 3, 2011. Standard registration ends May 2, 2011. There will be onsite registration. The cost of registration is as follows:
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.
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.
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2010 and Federal Fiscal Year 2011
This notice contains charts providing the States' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2010 and the preliminary QI allotments for FY 2011. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation.
SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval
The Food and Drug Administration (FDA) is announcing that it intends to refer for review before an advisory committee Ethicon Endo- Surgery Inc.'s (EES's), petition for review of the Agency's denial of premarket approval for its SEDASYS computer-assisted personalized sedation system (SEDASYS system).
Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV
The Food and Drug Administration (FDA) has determined the regulatory review period for VPRIV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ATRYN
The Food and Drug Administration (FDA) has determined the regulatory review period for ATRYN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Guidelines for Determining Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Revision of Guidelines on Non-Radiogenic Cancers
The Department of Health and Human Services (HHS) is proposing to treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). Under current guidelines HHS promulgated as regulations in 2002, all types of cancers except for CLL are treated as being potentially caused by radiation and hence as potentially compensable under EEOICPA. HHS proposes to reverse its decision to exclude CLL from such treatment.
Decision To Evaluate a Petition To Designate a Class of Employees From Mathieson Chemical Co., Pasadena, TX, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Mathieson Chemical Co., Pasadena, Texas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mathieson Chemical Co. Location: Pasadena, Texas. Job Titles and/or Job Duties: All employees. Period of Employment: 1951 through October 2009.
Meeting of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.
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