[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Rules and Regulations]
[Pages 32658-32659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13820]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 106, 107, 312, and 803
[Docket No. FDA-2010-N-0010]
Change of Contact Information; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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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.
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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
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1. The authority citation for 21 CFR part 106 continues to read as
follows:
Authority: 21 U.S.C. 321, 350a, 371.
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2. Section 106.120 is amended by revising paragraph (b) to read as
follows:
Sec. 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
[[Page 32659]]
the appropriate Food and Drug Administration district office specified
in part 5, subpart M of this chapter.
PART 107--INFANT FORMULA
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3. The authority citation for 21 CFR part 107 continues to read as
follows:
Authority: 21 U.S.C. 321, 343, 350a, 371.
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4. Section 107.50 is amended by revising paragraph (e)(2) to read as
follows:
Sec. 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.
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5. Section 107.240 is amended by revising paragraph (b) to read as
follows:
Sec. 107.240 Notification requirements.
* * * * *
(b) Method of notification. The notification made pursuant to Sec.
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
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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.
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7. Section 312.310 is amended by revising paragraph (d)(1) to read as
follows:
Sec. 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: [email protected]. 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: [email protected]. 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: [email protected].
* * * * *
PART 803--MEDICAL DEVICE REPORTING
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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.
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9. Section 803.12 is amended by revising paragraph (c) to read as
follows:
Sec. 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 [email protected] or a fax report to 301-847-8544.
* * * * *
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13820 Filed 6-8-10; 8:45 am]
BILLING CODE 4160-01-S