[Federal Register: January 10, 2006 (Volume 71, Number 6)]
[Rules and Regulations]
[Page 1488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja06-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
Medical Device Reporting
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 medical
device reporting regulations to reflect a change in address for agency
contacts for reporting a public health emergency. This action is
editorial in nature and is intended to improve the accuracy of the
agency's regulations.
DATES: This rule is effective January 10, 2006.
FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices
and Radiological Health, Office of Surveillance and Biometrics (HFZ-
530), 1350 Piccard Dr., Rockville, MD 20850, 301-827-2983.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
part 803.12(c) to reflect a reorganization affecting the agency
contacts for reporting public health emergencies. The current address
for reporting a public health emergency to FDA is the FDA Emergency
Operations Branch (HFC-162), Office of Regional Operations, at 301-443-
1240, followed by the submission of a fax to 301-443-3757. The new
contact is the FDA Office of Emergency Operations (HFA-615), Office of
Crisis Management, Office of the Commissioner, at 301-443-1240. This
report can be followed by an e-mail to emergency.operations@fda.hhs.gov
or a fax report sent to 301-827-3333. This document is published as a
final rule with the effective date given previously. Because the final
rule is an administrative action, FDA has determined that it has no
substantive impact on the public. It imposes no costs, and merely
updates contact information included in the Code of Federal Regulations
(CFR) for the convenience of the public. FDA, therefore, for good
cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and
public comment are unnecessary and that this rule may take effect upon
publication.
List of Subjects in 21 CFR Part 803
Imports, Medical devices, Medical device reporting, Reporting and
recordkeeping requirements.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and
underauthority delegated to the Commissioner of Food and Drugs, 21 CFR
part 803 is amended as follows:
PART 803--MEDICAL DEVICE REPORTING
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1. 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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2. 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?
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(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 (HFA-615), Office of Crisis Management, Office of
the Commissioner, at 301-443-1240, followed by the submission of an e-
mail to emergency.operations@fda.hhs.gov or a fax report to 301-827-
3333.
* * * * *
Dated: January 3. 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-172 Filed 1-9-06; 8:45 am]
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