Department of Health and Human Services June 11, 2014 – Federal Register Recent Federal Regulation Documents
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Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish: Availability of Draft Update
In March 2004, the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) (the Agencies) jointly released a document entitled ``What You Need to Know About Mercury in Fish and Shellfish'' (the 2004 advice). FDA and EPA are now announcing a draft update that contains both advice and supplemental questions and answers for those who want to understand the advice in greater detail. FDA and EPA are establishing a public docket and seeking public comment on both the substance of the advice and how best to frame the advice for consumers so that it is both understandable and influential. In addition to inviting public comments, the Agencies intend to seek the input of the FDA Advisory Committee on Risk Communication in a meeting open to the public. The Agencies may also hold public meetings in various locations around the country. Information about any such meetings will be published in the Federal Register once dates and locations are confirmed.
Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products-Recommended Practices; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological ProductsRecommended Practices.'' This guidance describes FDA's current thinking on recommended practices for drug manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs for human use, including drugs licensed as biological products, and approved animal drugs. The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling.
Global Unique Device Identification Database; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Global Unique Device Identification Database (GUDID): Guidance for Industry''. FDA has updated sections of the document, ``Global Unique Device Identification (GUDID): Draft Guidance for Industry'' in order to finalize the sections with the most questions from GUDID submitters. The guidance includes information about how device labelers (in most instances, the device manufacturer) will interface with the GUDID by establishing GUDID accounts and beginning their initial submissions. Draft guidance sections on the device identifier (DI) module have not been finalized in this document and will be addressed in a future document.
Determination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib
The Food and Drug Administration (FDA) has determined the regulatory review period for VANDETANIB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO) for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib
The Food and Drug Administration (FDA) has determined the regulatory review period for Vandetanib and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product. This draft guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA.
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of May 13, 2014, for the final rule that appeared in the Federal Register of April 11, 2014, and that amended the color additive regulations to expand the permitted use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis) as a color additive in food.
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