Department of Health and Human Services January 24, 2011 – Federal Register Recent Federal Regulation Documents

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), announces a public meeting of an independent scientific peer review panel (Panel) to evaluate the validation status of LUMI-CELL[supreg] ER (BG1Luc ER TA), an in vitro transcriptional activation (TA) assay used to identify chemicals that can interact with human estrogen receptors (ERs). Validated assays that can detect the interaction of chemicals with specific hormone receptors, including ERs, have been accepted and included in the U.S. Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program (EDSP) (https://www.epa.gov/endo/pubs/ assayvalidation/status.htm). Consequently, the BG1Luc ER TA may be applicable for addressing the ER TA component of the EPA EDSP Tier 1 screening battery. At this meeting, the Panel will review the draft BRD for the BG1Luc ER TA and evaluate the extent to which established validation and acceptance criteria have been appropriately addressed. The Panel also will be asked to comment on the extent to which the information included in the BRD supports ICCVAM's draft test method recommendations. NICEATM invites public comments on the draft BRD and draft ICCVAM test method recommendations. These documents are available on the NICEATM-ICCVAM Web site at: https://iccvam.niehs.nih.gov/methods/ endocrine/PeerPanel11.htm.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the draft, Current Intelligence Bulletin (CIB): Derivation of Immediately Dangerous to Life and Health (IDLH) Values. NIOSH is requesting technical review of the draft CIB. The draft document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/docket/review/docket156/default.html . Public Comment Period: Comments must be received by March 15, 2011. A public meeting to be convened either in Cincinnati, Ohio or via Teleweb may be scheduled at a date and time to be announced later if determined to be necessary. This public meeting will be announced via a subsequent notice.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information request regarding the Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.

The Food and Drug Administration (FDA) is reopening until February 23, 2011, the comment period for the notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request for Comments, published in the Federal Register of August 9, 2010 (75 FR 47820). In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period to permit public consideration of late-received comments and to provide an opportunity for all interested parties to provide information and share views on the matter.