5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Ann Meeker O’Connell at 301-7963150, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301827-1800, or (CDRH) Chrissy Cochran at 301-796-5490. U.S. Department of Health and…
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