The Office of Combination Products (Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930,, e-mail: combination@fda.gov, is the designated product jurisdiction officer. [68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006; 75 FR 13678, Mar. 23, 2010]