distribution, display, etc. QUESTION: When a for-profit company files for approval from the Federal Drug Administration, either for a new drug or medical device, the company must provide copies of all articles and other literature, along with the filing. Now, in Europe, there is a Medical Device directive, MEDDEV.2.7.1 Rev.3-Guidelines on Medical Devices, that requires all manufacturers who want to sell product in European Union countries to provide a clinical evaluation of their product. Part of the evaluation is a literature search, along with copies of the articles and other materials that support their evaluation. Must copyright royalties be paid for these copies provided in response to a government directive? ANSWER: If the company has a Copyright Clearance Center annual copyright license (often called a blanket license), the librarian can provide copies of these articles to accompany federal and international filings without concern. If the company does not have a CCC license, then it should look at its various license agreements for full-text journals to see if this activity is covered by the license agreement. Otherwise, royalties should be paid. QUESTION: A librarian with curatorial responsibilities for a university library music collection is making an educational/promotional film about one of the collection's donors, a classical musician of note. As a member a performance group, the donor made many classical music recordings on the Philips label, and the librarian wants to obtain permission from Philips Records to use part of one track from one of these recordings in the film. The film is part of the fund-raising efforts to support the collection. ANSWER: Assuming that the music on the recording is under copyright, the right the librarian is seeking is called the synchronization or "synch" right which involves the use of a recording of a musical work in audiovisual form such as in a film. It is called the synchronization right because the music is "synchronized," or recorded in timed relation with the visual images. The music publisher synch rights are licensed by the music publisher (the publisher of the sheet music) and not the recording company. Sound recordings do not have public performance rights, and the sync right is a part of the right of public performance.

insights-library-archivaland-information-sciences.