Medical Device Reporting, 1488 [06-172]

Download as PDF 1488 Federal Register / Vol. 71, No. 6 / Tuesday, January 10, 2006 / Rules and Regulations rmajette on PROD1PC70 with NOTICES pieces. This must be demonstrated by testing to failure. 3. Component Strength. The glass component must be strong enough to meet the load requirements for all flight and landing loads including any of the applicable emergency landing conditions in subparts C & D of part 25. Abuse loading without failure, such as impact from occupants stumbling into, leaning against, sitting on, or performing other intentional or unintentional forceful contact must also be demonstrated. This must be demonstrated by static structural testing to ultimate load, except that the critical loading condition must be tested to failure in the as-installed condition. The tested glass must have all features that effect component strength, such as etched surfaces, cut or engraved designs, holes, and so forth. Glass pieces must be non-hazardous. 4. Component Retention. The glass component, as installed in the airplane, must not come free of its restraint or mounting system in the event of an emergency landing. A test must be performed to demonstrate that the occupants would be protected from the effects of the component failing or becoming free of restraint under dynamic loading. The dynamic loading of § 25.562(b)(2) is considered an acceptable dynamic event. The applicant may propose an alternate pulse, however, the impulse and peak load may not be less than that of § 25.562(b)(2). As an alternative to a dynamic test, static testing may be used if the loading is assessed as equivalent or more critical than a dynamic test, based upon validated dynamic analysis. Both the primary directional loading and rebound conditions need to be assessed. 5. Instruction for Continued Airworthiness. The instruction for continued airworthiness will reflect the fastening method used and will ensure the reliability of the methods used (e.g., life limit of adhesives, or clamp connection). Inspection methods and intervals will be defined based upon adhesion data from the manufacturer of the adhesive or actual adhesion test data, if necessary. Issued in Renton, Washington, on January 3, 2006. Kalene C. Yanamura, Acting Manager, Transport Airplane Directorate Aircraft Certification Service. [FR Doc. 06–200 Filed 1–9–06; 8:45 am] BILLING CODE 4910–13–P VerDate Aug<31>2005 14:38 Jan 09, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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: I 21 CFR Part 803 PART 803—MEDICAL DEVICE REPORTING Medical Device Reporting AGENCY: Food and Drug Administration, HHS. 1. The authority citation for 21 CFR part 803 continues to read as follows: Final rule; technical amendment. Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374. ACTION: 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. SUMMARY: List of Subjects in 21 CFR Part 803 Imports, Medical devices, Medical device reporting, Reporting and recordkeeping requirements. PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 I 2. Section 803.12 is amended by revising paragraph (c) to read as follows: I § 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 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] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 946 [VA–122–FOR] Virginia Regulatory Program Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Final rule; approval of amendment. AGENCY: SUMMARY: We are approving an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The program amendment revises the Virginia Coal Surface Mining Reclamation Regulations. The amendment reflects changes in the renumbering of Virginia Code section references to the Virginia Administrative Process Act; clarification regarding the filing of requests for formal hearing and judicial review; revisions of the Virginia rules to be consistent with amendments to the E:\FR\FM\10JAR1.SGM 10JAR1

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[Federal Register Volume 71, Number 6 (Tuesday, January 10, 2006)]
[Rules and Regulations]
[Page 1488]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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.

0
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

0
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.

0
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 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]
BILLING CODE 4160-01-S

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