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.

Rules and Regulations Federal Register

47523 

Vol. 73, No. 158 

Thursday, August 14, 2008 

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 

DEPARTMENT OF STATE 

22 CFR Part 121 

[Public Notice 6316] 

RIN 1400–AC47 

Amendment to the International Traffic 

in Arms Regulations: The United 

States Munitions List Category VIII 

AGENCY: Department of State. 

ACTION: Final rule. 

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 

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 


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