[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR106.120] [Page 189-190] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents Subpart D--Notification Requirements Sec. 106.120 New formulations and reformulations. (a) Information required by section 412(b)(2) and (3) of the act shall be submitted to Center for Food Safety and Applied Nutrition (HFS- 830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (b) The manufacturer shall promptly notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(c)(2) of the act) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by section 412(g) of the act and by regulations promulgated under section 412(a)(2) of the act, or when there is an infant formula that is otherwise adulterated or misbranded and that may present risk to human health. This notification shall be made, by telephone, to the Director of the appropriate Food and Drug Administration district office specified in Sec. 5.215 of this chapter. After normal business hours (8 a.m. to 4:30 p.m.) the FDA emergency number, 301-443-1240, shall be used. The manufacturer shall send a followup written confirmation to the [[Page 190]] Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to the appropriate Food and Drug Administration district office specified in Sec. 5.215. [47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001]