Department of Health and Human Services March 1, 2007 – Federal Register Recent Federal Regulation Documents
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New Animal Drugs For Use in Animal Feeds; Monensin
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 Elanco Animal Health. The supplemental NADA provides for minor revisions to labeling of monensin Type A medicated articles for chickens. FDA is also amending the regulations to simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin for poultry and game birds. This action is being taken to improve the clarity of the regulations.
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for the addition of tylosin tartrate to an approved subcutaneous implant containing trenbolone and estradiol used for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter.
The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device regulations. These 2-day seminars, which are designed to address the training needs of start up and small device manufacturers and their suppliers, will include both industry and FDA perspectives and a question and answer period. Dates: The seminars are planned for the following dates: 1. March 15 and 16, 2007, in Irvine, CA 92614. Details about dates are posted on AdvaMed's Web site at: www.advamed.org/irvine.\1\
New Animal Drugs For Use in Animal Feeds; Zilpaterol
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 Intervet Inc. The supplemental NADA provides for the removal of a caution statement against the formulation of pelleted feeds from labeling of zilpaterol hydrochloride Type A medicated article and Type B and Type C medicated feeds.
New Animal Drugs; Maropitant
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two new animal drug applications (NADAs) filed by Pfizer, Inc. The NADAs provide for the veterinary prescription use of maropitant citrate tablets and maropitant citrate injectable solution for the management of vomiting in dogs.
Department of Health and Human Services' Implementation of OMB Guidance on Nonprocurement Debarment and Suspension
The Department of Health and Human Services (HHS or the Department) is issuing a new part 376 on nonprocurement debarment and suspension in Title 2 the Code of Federal Regulations (CFR). This new part is HHS's implementation of OMB's guidance provided at 2 CFR part 180. HHS is removing 45 CFR part 76, the part containing its implementation of the government-wide common rule on nonprocurement debarment and suspension. The new part in 2 CFR serves the same purpose as the common rule, but in a simpler way. This interim final rule is part of OMB's initiative to streamline and consolidate all federal regulations on nonprocurement debarment and suspension. It is an administrative simplification that would make no substantive change in HHS policy or procedures for nonprocurement debarment and suspension.
Notice of Availability: Secretarial Acceptance and Planned Recognition of Certain Healthcare Information Technology Standards Panel (HITSP) Interoperability Specifications for Health Information Technology
By publication of this document, we are informing the public of the Secretary's acceptance and planned recognition of certain Healthcare Information Technology Standards Panel (HITSP) Interoperability Specifications for health information technology as interoperability standards. The Secretary accepted these standards, version 1.2, in December of 2006, and intends to recognize them in the version 2.0 form in December of 2007, presuming that changes from version 1.2 to version 2.0 are minor and of a technical nature. This list of accepted HITSP standards is available at https://www.hitsp.org and click on ``HITSP Interoperability Specifications HERE'' box.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the 12th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Ames Laboratory in Ames, Iowa, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Ames Laboratory in Ames, Iowa, 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: Ames Laboratory. Location: Ames, Iowa. Job Titles and/or Job Duties: All sheet metal workers, physical plant maintenance and associated support staff (includes all maintenance shop personnel) of Ames Laboratory and supervisory staff that may have been exposed to the maintenance and renovation activities of the thorium production areas in Wilhelm Hall (also known as the Metallurgy Building or ``Old'' Metallurgy Building). Period of Employment: January 1, 1955 through December 31, 1970.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Hanford in Richland, Washington, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Hanford in Richland, Washington, 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: Hanford. Location: Richland, Washington. Job Titles and/or Job Duties: All roving maintenance carpenters and apprentice carpenters who worked in the 100, 200, 300, and 400 Areas. Period of Employment: April 25, 1967 through February 1, 1971.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at W.R. Grace in Erwin, Tennessee, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at W.R. Grace in Erwin, Tennessee, 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: W.R. Grace. Location: Erwin, Tennessee. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1958 through December 31, 1970.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employee at the Allied Chemical Corporation Plant in Metropolis, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 1, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
the Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Harshaw Harvard- Denison Plant in Cleveland, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 1, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
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