Medical Devices; Radiology Devices; Reclassification of Bone Sonometers, 47523 [E8-18792]

Download as PDF 47523 Rules and Regulations Federal Register Vol. 73, No. 158 Thursday, August 14, 2008 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. will not have a significant economic impact on a substantial number of small entities.’’ Dated: August 8, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–18792 Filed 8–13–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF STATE Food and Drug Administration [Public Notice 6316] 21 CFR Part 892 RIN 1400–AC47 [Docket No. FDA–2005–N–0346] (formerly 2005N–0467) Amendment to the International Traffic in Arms Regulations: The United States Munitions List Category VIII 22 CFR Part 121 Medical Devices; Radiology Devices; Reclassification of Bone Sonometers AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of July 17, 2008 (73 FR 40967). The final rule reclassified bone sonometer devices from class III into class II, subject to special controls. The document contained an inadvertent error regarding the impact of the final rule on small businesses. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and Radiological Health (HFZ–215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276– 2342. In FR Doc. E8–16354, appearing on page 40969 in the Federal Register of Thursday, July 17, 2008, there was an error regarding the impact of the final rule on small businesses. Specifically, language certifying that the final rule meets the requirements of the Regulatory Flexibility Act (5 U.S.C. 601–612) was inadvertently omitted during document preparation. Accordingly, the following correction is made: 1. On page 40969, in the middle column, under section ‘‘VI. Analysis of Impacts,’’ in the second full paragraph, the third sentence is revised to read: ‘‘The agency certifies that the final rule rfrederick on PROD1PC67 with RULES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 14:45 Aug 13, 2008 Jkt 214001 Department of State. Final rule. AGENCY: ACTION: SUMMARY: The Department of State is amending the text of the International Traffic in Arms Regulations (ITAR), Part 121 to add language clarifying how the criteria of Section 17(c) of the Export Administration Act of 1979 (‘‘EAA’’) are implemented in accordance with the Department of State’s obligations under the Arms Export Control Act (‘‘AECA’’), and restating the Department’s longstanding policy and practice of implementing the criteria of this provision. DATES: Effective Date: This rule is effective August 14, 2008. FOR FURTHER INFORMATION CONTACT: Director Ann Ganzer, Office Defense Trade Controls Policy, Department of State, Telephone (202) 663–2792 or Fax (202) 261–8199; e-mail DDTCResponseTeam@state.gov. ATTN: Regulatory Change, ITAR Part 121. SUPPLEMENTARY INFORMATION: On April 11, 2008, the Department published a Notice of Proposed Rulemaking (NPRM) to add language clarifying how the criteria of Section 17(c) of the Export Administration Act of 1979 are implemented in accordance with the Arms Export Control Act by amending Category VIII *(b), (h), and the Note. Further background is provided with the NPRM at 73 FR 19778. This rule reinstates the Section 17(c) reference in the ITAR to assist exporters in understanding the scope and application of the Section 17(c) criteria PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 to parts and components for civil aircraft. It also clarifies that any part or component that (a) is standard equipment; (b) is covered by a civil aircraft type certificate (including amended type certificates and supplemental type certificates) issued by the Federal Aviation Administration for civil, non-military aircraft (this expressly excludes military aircraft certified as restricted and any type certification of Military Commercial Derivative Aircraft, defined by FAA Order 8110.101 effective date September 7, 2007 as ‘‘civil aircraft procured or acquired by the military’’); and (c) is an integral part of such civil aircraft, is subject to the jurisdiction of the Export Administrative Regulations (EAR). Where such part or component is not Significant Military Equipment (‘‘SME’’), no Commodity Jurisdiction (CJ) determination is required to determine whether the item meets these criteria for exclusion under the United States Munitions List (USML), unless doubt exists as to whether these criteria have been met. However, where the part or component is SME, a CJ determination is always required, except where a SME part or component was integral to civil aircraft prior to the effective date of this rule. Additionally, this proposed rule adds language in a new Note after Category VIII(h) to provide guidelines concerning the parts or components meeting these criteria. The change to Category VIII*(b) also identifies and designates certain sensitive military items, heretofore controlled under Category VIII(h), as SME. Previous and current authorizations concerning the manufacturer of these items will not require notification in accordance with § 124.11, and will not require a ‘‘Nontransfer and Use Certificate’’ DSP– 83, unless they are amended, modified, or renewed. This requirement for a CJ determination by the Department of State helps ensure the U.S. Government is made aware of, and can reach an informed decision regarding, any sensitive military item proposed for standardization in the commercial aircraft industry before the item or technology is actually applied to a commercial aircraft program, whether such item is integral to the aircraft, and, if so, whether the development, production, and use of the technology E:\FR\FM\14AUR1.SGM 14AUR1

Agencies

[Federal Register Volume 73, Number 158 (Thursday, August 14, 2008)]
[Rules and Regulations]
[Page 47523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18792]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 73, No. 158 / Thursday, August 14, 2008 / 
Rules and Regulations

[[Page 47523]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2005-N-0346] (formerly 2005N-0467)


Medical Devices; Radiology Devices; Reclassification of Bone 
Sonometers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of July 17, 2008 (73 FR 
40967). The final rule reclassified bone sonometer devices from class 
III into class II, subject to special controls. The document contained 
an inadvertent error regarding the impact of the final rule on small 
businesses. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and 
Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2342.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-16354, appearing on page 40969 
in the Federal Register of Thursday, July 17, 2008, there was an error 
regarding the impact of the final rule on small businesses. 
Specifically, language certifying that the final rule meets the 
requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612) was 
inadvertently omitted during document preparation. Accordingly, the 
following correction is made:
    1. On page 40969, in the middle column, under section ``VI. 
Analysis of Impacts,'' in the second full paragraph, the third sentence 
is revised to read: ``The agency certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.''

    Dated: August 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18792 Filed 8-13-08; 8:45 am]
BILLING CODE 4160-01-S
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