2010-13820. Change of Contact Information; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending its regulations to reflect changes in the contact information for the FDA Emergency Call Center. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

DATES:

This rule is effective June 11, 2010.

FOR FURTHER INFORMATION CONTACT:

Wayne Gorski, Office of Crisis Management, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 2300, Silver Spring, MD 20993-0002, 301-796-8248.

SUPPLEMENTARY INFORMATION:

FDA is amending its regulations in 21 CFR parts 106, 107, 312, and 803 to reflect a change in the telephone and fax numbers for the FDA Emergency Call Center. The phone number will change from 301-443-1240 to 866-300-4374 on June 11, 2010. The fax number will change from 301-827-3333 to 301-847-8544. We have also amended the regulations to reflect that the new phone and fax numbers are for the “FDA Emergency Call Center”.

Publication of this document constitutes final action on this change under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedures are unnecessary because FDA is merely updating nonsubstantive content.

List of Subjects

21 CFR Part 106

• Food grades and standards
• Infants and children
• Nutrition
• Reporting and recordkeeping requirements

21 CFR Part 107

• Food labeling
• Infants and children
• Nutrition
• Reporting and recordkeeping requirements
• Signs and symbols

21 CFR Part 312

• Drugs
• Exports
• Imports
• Investigations
• Labeling
• Medical research
• Reporting and recordkeeping requirements
• Safety

21 CFR Part 803

• Imports
• Medical devices
• Reporting and recordkeeping requirements

Therefore under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR Chapter I is amended as follows:

PART 106—INFANT FORMULA QUALITY CONTROL PROCEDURES

1. The authority citation for 21 CFR part 106 continues to read as follows:

Authority: 21 U.S.C. 321, 350a, 371.

2. Section 106.120 is amended by revising paragraph (b) to read as follows:

§ 106.120

New formulations and reformulations.

(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 part 5, subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374. The manufacturer shall send a followup written confirmation to the 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 part 5, subpart M of this chapter.

PART 107—INFANT FORMULA

3. The authority citation for 21 CFR part 107 continues to read as follows:

Authority: 21 U.S.C. 321, 343, 350a, 371.

4. Section 107.50 is amended by revising paragraph (e)(2) to read as follows:

§ 107.50

Terms and conditions.

(e) * * *

(2) The manufacturer shall promptly notify FDA when the manufacturer has knowledge (as defined in section 412(c)(2) of the act) that reasonably supports the conclusion that an exempt 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 paragraph (b) or (c) of this section, or when there is an exempt infant formula that may be otherwise adulterated or misbranded and if so adulterated or misbranded presents a risk of human health. This notification shall be made, by telephone, to the Director of the appropriate FDA district office specified in part 5, subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374. The manufacturer shall send a followup written confirmation to the 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 FDA district office specified in part 5, subpart M of this chapter.

5. Section 107.240 is amended by revising paragraph (b) to read as follows:

§ 107.240

Notification requirements.

(b) Method of notification. The notification made pursuant to § 107.240(a) shall be made, by telephone, to the Director of the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374. The manufacturer shall send written confirmation of the notification to the 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 listed in part 5, subpart M of this chapter.

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

6. The authority citation for 21 CFR part 312 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

7. Section 312.310 is amended by revising paragraph (d)(1) to read as follows:

§ 312.310

Individual patients, including for emergency use.

(d) * * *

(1) Emergency expanded access use may be requested by telephone, facsimile, or other means of electronic communications. For investigational biological drug products regulated by the Center for Biologics Evaluation and Research, the request should be directed to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 301-827-1800 or 1-800-835-4709, e-mail: [e-mail]. For all other investigational drugs, the request for authorization should be directed to the Division of Drug Information, Center for Drug Evaluation and Research, 301-796-3400, e-mail: [e-mail]. After normal working hours (8 a.m. to 4:30 p.m.), the request should be directed to the FDA Emergency Call Center, 866-300-4374, e-mail: [e-mail].

PART 803—MEDICAL DEVICE REPORTING

8. The authority citation for 21 CFR part 803 continues to read as follows:

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

9. Section 803.12 is amended by revising paragraph (c) to read as follows:

§ 803.12

Where and how do I submit reports and additional information?

(c) If an entity is confronted with a public health emergency, this can be brought to FDA's attention by contacting the FDA Office of Emergency Operations, Office of Crisis Management, Office of the Commissioner, at 866-300-4374, followed by the submission of an e-mail to [e-mail] or a fax report to 301-847-8544.

Dated: June 4, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.