Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal
The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing approval of the NADAs.
Privacy Act of 1974, New OIG Privacy Act System of Records: Administrative Files
The Office of Inspector General (OIG) is proposing a new system of records, entitled ``Administrative Files'' (09-90-0076). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the Federal Register when there is a revision, change, or addition. This system of records contains certain administrative files for the purpose of maintaining, archiving, and filing records.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Non-Animal Methods and Approach for Evaluating Eye Irritation Potential for Antimicrobial Cleaning Products (AMCPs): Request for Nominations for an Independent Expert Panel and Submission of Relevant Data
At the request of the U.S. Environmental Protection Agency (EPA), the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is planning to assess the validation status of a proposed non-animal approach for evaluating the eye irritation potential of AMCPs that meets hazard classification and labeling requirements. On behalf of ICCVAM, NICEATM requests: 1. Nominations of expert scientists to serve as members of an independent peer review panel. 2. Submission of relevant data and information on AMCPs or related substances obtained from (1) human testing or experience including reports from accidental exposures, (2) rabbits using the standard eye test or the low volume eye test (LVET), and (3) in vitro test methods for assessing ocular irritation, such as the Bovine Corneal Opacity and Permeability (BCOP) test, the Cytosensor Microphysiometer (CM) test, and the EpiOcular test, and data supporting the accuracy and reproducibility of these methods.
Medicaid Program: Home and Community-Based State Plan Services
This proposed rule would amend the Medicaid regulations to define and describe home and community-based State plan services implementing new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005.