Department of Health and Human Services December 10, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Electronic Margin of Safety and NonClinical Toxicology Study Data Submission; Notice of Pilot Project
The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) is seeking sponsors interested in participating in a pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format which is used to support review activity. FDA anticipates that a successful pilot will enable CVM to accept margin of safety and nonclinical toxicology study data related to investigational new animal drug (INAD) files and new animal drug applications (NADA's) electronically in SEND format.
Decision to Evaluate a Petition to Designate a Class of Employees of Area IV of the Santa Susana Field Laboratory, 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 of Area IV of the Santa Susana Field Laboratory 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:
Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP).'' Elsewhere in this issue of the Federal Register, we are issuing final regulations on CGMPs for positron emission tomography (PET) drugs. We are issuing the guidance to help PET drug producers better understand FDA's thinking concerning compliance with the PET CGMP regulations.
Current Good Manufacturing Practice for Positron Emission Tomography Drugs
The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP).''
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010; Corrections
This document corrects several technical and typographical errors in the final rule with comment period that appeared in the November 25, 2009, Federal Register entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010''.
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