Department of Health and Human Services March 30, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Target Product ProfileA Strategic Development Process Tool.'' The purpose of this guidance is to inform sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) of the availability and potential usefulness of a target product profile (TPP). A TPP can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. This draft guidance describes the purposes of a TPP, provides guidance on how to complete a TPP, makes suggestions on how to best use a TPP, and relates case studies that demonstrate the potential usefulness of a TPP.

Amendments to the Federal Food, Drug, and Cosmetic Act (the act) necessitate several changes to the citations used in Food and Drug Administration (FDA) regulations regarding the prescription-exemption procedure and the list of new drugs that are exempted from the prescription-dispensing requirements. These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the mental models study of food bioterrorism risk awareness.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2006 through December 2006, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.