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

The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes presentations from key FDA officials, global regulators, and industry experts. The public conference has three separate tracks of interest for quality, regulatory affairs, and clinical research professionals, and is intended for companies of all sizes and employees at all levels.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.'' This guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standards for standardized numerical identifiers for prescription drugs.

The Food and Drug Administration (FDA) is amending its regulations on public hearings before public advisory committees to reflect an internal change with respect to the staff that handles the nomination and selection process for nonvoting members representing consumer interests for standing technical advisory committees. FDA is

This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to Native American Tribes (including Alaska Native Villages) and Tribal organizations. The purpose of these grants is to assist Tribes in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents (42 U.S.C. 10401).

The Food and Drug Administration (FDA) is opening a comment period for submission of suggestions for revising the guidance for industry published in the Federal Register July 30, 2009, entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' In addition, FDA, along with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America, is sponsoring a public conference to be held on March 24 and 25, 2010, to discuss and debate issues contained in the published guidance document. The purpose of the conference is to consider the effect of the recommendations in the guidance since its publication, and to seek suggestions for future revisions that will incorporate the views expressed.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bottled Water: Total Coliform and E. coliSmall Entity Compliance Guide'' for a final rule published in the Federal Register of May 29, 2009. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

The Food and Drug Administration is proposing to amend its regulations governing medical device establishment registration and device listing. The proposed revisions would modify FDA's current regulations at part 807 (21 CFR part 807) to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), which was enacted on September 27, 2007, amended section 510 of the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In accordance with FDAAA, the agency launched FDA's Unified Registration and Listing System (FURLS), and Internet-based registration and listing system. FDAAA requires electronic submission of device registration and listing information unless FDA grants a waiver request.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2009 through December 2009, 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, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities.

The Food and Drug Administration (FDA) has determined that DIDREX (benzphetamine hydrochloride (HCl)) Tablets, 25 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for benzphetamine HCl 25 mg tablets, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), and more specifically, this guidance provides information to the industry on submitting a single reportable food report to FDA covering reportable food located at more than one of a company's facilities.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.