[Federal Register Volume 71, Number 6 (Tuesday, January 10, 2006)]
[Rules and Regulations]
[Page 1488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-172]


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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 [email protected] 
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?

* * * * *
    (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 [email protected] 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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