Department of Health and Human Services February 2010 – Federal Register Recent Federal Regulation Documents

This document corrects typographical errors that appeared in the notice published in the January 28, 2010, Federal Register entitled ``Findings of Misconduct in Science.''

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The purpose of this notice is to allow 60 days for public comment.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Contents of a Complete Submission for the Evaluation of Proprietary Names'' (proprietary names submission guidance). This guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

A notice was published in the Federal Register on Tuesday, Feb. 2, 2010, to announce a meeting of the President's Advisory Council on Faith-Based and Neighborhood Partnerships that was scheduled to be held on Tuesday, Feb. 9th, 2010. This meeting has been cancelled in its entirety. We will publish a new notice when the meeting has been rescheduled.

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 reporting requirements for the information collection activity ``How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter In Electronic Format to the Center for Veterinary Medicine.''

The Food and Drug Administration (FDA) is confirming the effective date of December 8, 2009, for the final rule that appeared in the Federal Register of November 5, 2009. The final rule amended the color additive regulations to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.

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 reporting requirements regarding how to use e-mail to submit a request for a meeting or teleconference in electronic format to the Center for Veterinary Medicine (CVM).