Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations 66747 

(ii) If the inspections were done prior to 

the effective date of this AD: Within 30 days 

after the effective date of this AD. 

FAA AD Differences 

Note: This AD differs from the MCAI and/ 

or service information as follows: Although 

the MCAI allows further flight after cracks 

are found during compliance with the 

required action, this AD requires that you 

repair the crack(s) before further flight. 

Other FAA AD Provisions 

(g) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. Send 

information to ATTN: Dan Rodina, 

Aerospace Engineer, International Branch, 

ANM–116, Transport Airplane Directorate, 

FAA, 1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone (425) 

227–2125; fax (425) 227–1149. Before using 

any approved AMOC on any airplane to 

which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act, 

the Office of Management and Budget (OMB) 

has approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(h) Refer to MCAI European Aviation 

Safety Agency (EASA) Airworthiness 

Directive 2008–0066, dated March 31, 2008; 

Airbus Service Bulletin A310–54–2032, 

Revision 01, dated October 8, 2007; and 

Airbus Mandatory Service Bulletin A310–54– 

2036, Revision 02, dated September 28, 2007; 

for related information. 

Material Incorporated by Reference 

(i) You must use Airbus Service Bulletin 

A310–54–2032, Revision 01, dated October 8, 

2007; and Airbus Mandatory Service Bulletin 

A310–54–2036, including Appendix 01, 

Revision 02, dated September 28, 2007; as 

applicable; to do the actions required by this 

AD, unless the AD specifies otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Airbus, 1 Rond Point 

Maurice Bellonte, 31707 Blagnac Cedex, 

France; telephone +33 5 61 93 33 33; Internet 

http://www.airbus.com. 

(3) You may review copies at the FAA, 

Transport Airplane Directorate, 1601 Lind 

Avenue, SW., Renton, Washington; or at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

(202) 741–6030, or go to: http:// 

www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on October 

9, 2008. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E8–25767 Filed 11–10–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2008–0667; Directorate 

Identifier 2008–NM–009–AD; Amendment 

39–15717; AD 2008–22–20] 

RIN 2120–AA64 

Airworthiness Directives; Airbus Model 

A330–200, A330–300, and A340–300 

Series Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for the 

products listed above. This AD results 

from mandatory continuing 

airworthiness information (MCAI) 

originated by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as: 

During fatigue tests (EF3) on the A340–600, 

damages were found in longitudinal doubler 

at VTP [vertical tail plane] attachment cutout 

between Frame (FR) 80 and FR86. This 

damage occurred between 58341 and 72891 

simulated Flight Cycles (FC). 

Due to the higher Design Service Goal and 

different design (e.g., doubler thickness) [of 

the] A330–200/–300 and A340–300 aircraft 

series, the damage assessment concluded 

[there was] potential impact on [the airplanes 

specified in the] applicability. 

* * * * * 

The unsafe condition is crack 

propagation in the VTP attachment 

cutout, which could reduce airplane 

structural integrity in the tail section. 

We are issuing this AD to require 

actions to correct the unsafe condition 

on these products. 

DATES: This AD becomes effective 

December 17, 2008. 

The Director of the Federal Register 

approved the incorporation by reference 

of certain publications listed in this AD 

as of December 17, 2008. 

ADDRESSES: You may examine the AD 

docket on the Internet at http:// 

www.regulations.gov or in person at the 

U.S. Department of Transportation, 

Docket Operations, M–30, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC. 

FOR FURTHER INFORMATION CONTACT: 

Vladimir Ulyanov, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone 

(425) 227–1138; fax (425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 to include an AD that would 

apply to the specified products. That 

NPRM was published in the Federal 

Register on June 24, 2008 (73 FR 35603). 

That NPRM proposed to correct an 

unsafe condition for the specified 

products. The MCAI states: 

During fatigue tests (EF3) on the A340–600, 

damages were found in longitudinal doubler 

at VTP [vertical tail plane] attachment cutout 

between Frame (FR) 80 and FR86. This 

damage occurred between 58341 and 72891 

simulated Flight Cycles (FC). 

Due to the higher Design Service Goal and 

different design (e.g., doubler thickness) [of 

the] A330–200/–300 and A340–300 aircraft 

series, the damage assessment concluded 

[there was] potential impact on [the airplanes 

specified in the] applicability. 

[T]o allow early detection of cracks, which 

could [prevent] possible crack propagation 

and consequently to maintain the structural 

integrity of the upper shell structure between 

FR80 and FR86, this Airworthiness Directive 

(AD) mandates an inspection program [for 

cracking] of this area using a high frequency 

eddy current (HFEC) method, and a 

modification to improve the upper shell 

structure. 

The unsafe condition is crack 

propagation in the VTP attachment 

cutout, which could reduce airplane 

structural integrity in the tail section. 

Corrective actions include doing eddy 

current inspections for cracking of 

certain fastener rows, and contacting 

Airbus for repair instructions and 

repairing. You may obtain further 

information by examining the MCAI in 

the AD docket. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. We 

considered the comment received. 

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66748 Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations 

Request To Allow Flight With Cracks 

Northwest Airlines (NWA) requests 

that we reconsider eliminating the 

provision for flight with certain cracks. 

NWA states that the MCAI and Airbus 

service bulletins (that were referenced 

in the NPRM as appropriate sources of 

service information) provide for flight 

with certain cracks if follow-on 

inspections are accomplished in 

accordance with the service bulletin. 

We do not concur. Our policy 

specifies the requirement to repair 

known cracks before further flight 

(though we may make exceptions to this 

policy in certain cases of unusual need, 

as discussed below). This policy is 

based on the fact that such damaged 

airplanes do not conform to the FAAcertificated type design and, therefore, 

are not airworthy until a properly 

approved repair is made. While 

recognizing that repair deferrals might 

be necessary at times, our policy is 

intended to minimize adverse human 

factors relating to the lack of reliability 

of long-term repetitive inspections, 

which might reduce the safety of the 

type-certificated design if such repair 

deferrals are practiced routinely. 

As noted above, we may make an 

exception to this policy in certain cases, 

if there is an unusual need for a 

temporary deferral. Unusual needs 

include such circumstances as 

legitimate difficulty in acquiring parts to 

accomplish repairs. Under such 

conditions, we may allow a temporary 

deferral of the repair, subject to a 

stringent inspection program acceptable 

to the FAA. We acknowledge that the 

manufacturer has specified inspection 

intervals that are intended to allow 

continued operation with known cracks, 

and to prevent the need for extensive 

repairs. However, since we are not 

aware of any unusual need for repair 

deferral in regard to this AD, we have 

not evaluated these inspection intervals. 

Under the provisions of paragraph 

(g)(1) of this AD, we will consider 

requests for approval of an AMOC if 

sufficient data are submitted to 

substantiate that temporary deferral of 

repair with follow-on inspections would 

provide an acceptable level of safety. 

We have not changed the AD in this 

regard. 

Actions Since NPRM Was Issued 

Airbus has issued revisions to two 

service bulletins referenced in the 

NPRM as appropriate sources of service 

information. Airbus Mandatory Service 

Bulletins A330–53–3168 and A340–53– 

4174, both Revision 01, both dated 

February 15, 2008, are essentially the 

same as the original versions of those 

service bulletins except for 

clarifications, and no additional work is 

required for airplanes modified per the 

original issue. We have changed the 

references in paragraphs (f)(1), (f)(2)(i), 

and (h) of this AD to include Revision 

01 of those service bulletins, and added 

paragraph (f)(4) to this AD to give credit 

for actions performed according to the 

original issues. 

Conclusion 

We reviewed the available data, 

including the comment received, and 

determined that air safety and the 

public interest require adopting the AD 

with the changes described previously. 

We determined that these changes will 

not increase the economic burden on 

any operator or increase the scope of the 

AD. 

Differences Between This AD and the 

MCAI or Service Information 

We have reviewed the MCAI and 

related service information and, in 

general, agree with their substance. But 

we might have found it necessary to use 

different words from those in the MCAI 

to ensure the AD is clear for U.S. 

operators and is enforceable. In making 

these changes, we do not intend to differ 

substantively from the information 

provided in the MCAI and related 

service information. 

We might also have required different 

actions in this AD from those in the 

MCAI in order to follow our FAA 

policies. Any such differences are 

highlighted in a Note within the AD. 

Costs of Compliance 

We estimate that this AD will affect 

about 26 products of U.S. registry. We 

also estimate that it will take about 202 

work-hours per product to comply with 

the basic requirements of this AD. The 

average labor rate is $80 per work-hour. 

Required parts will cost about $19,020 

per product. Where the service 

information lists required parts costs 

that are covered under warranty, we 

have assumed that there will be no 

charge for these parts. As we do not 

control warranty coverage for affected 

parties, some parties may incur costs 

higher than estimated here. Based on 

these figures, we estimate the cost of 

this AD to the U.S. operators to be 

$914,680, or $35,180 per product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this AD: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); and 

3. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this AD and placed it in the AD docket. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations office between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains the NPRM, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations office (telephone 

(800) 647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

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Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations 66749 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new AD: 

2008–22–20 Airbus: Amendment 39–15717. 

Docket No. FAA–2008–0667; Directorate 

Identifier 2008–NM–009–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective December 17, 2008. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Airbus Model A330– 

200, A330–300, and A340–300 series 

airplanes; certificated in any category; all 

certified models, all serial numbers; on 

which Airbus Modification 44205 has been 

embodied in production, except those on 

which Airbus Modification 52974 or 53223 

has been embodied in production. 

Subject 

(d) Air Transport Association (ATA) of 

America Code 53: Fuselage. 

Reason 

(e) The mandatory continuing 

airworthiness information (MCAI) states: 

During fatigue tests (EF3) on the A340–600, 

damages were found in longitudinal doubler 

at VTP [vertical tail plane] attachment cutout 

between Frame (FR) 80 and FR86. This 

damage occurred between 58341 and 72891 

simulated Flight Cycles (FC). 

Due to the higher Design Service Goal and 

different design (e.g., doubler thickness) [of 

the] A330–200/–300 and A340–300 aircraft 

series, the damage assessment concluded 

[there was] potential impact on [the airplanes 

specified in the] applicability. 

[T]o allow early detection of cracks, which 

could [prevent] possible crack propagation 

and consequently to maintain the structural 

integrity of the upper shell structure between 

FR80 and FR86, this Airworthiness Directive 

(AD) mandates an inspection program [for 

cracking] of this area using a high frequency 

eddy current (HFEC) method, and a 

modification to improve the upper shell 

structure. 

The unsafe condition is crack propagation in 

the VTP attachment cutout, which could 

reduce airplane structural integrity in the tail 

section. Corrective actions include doing 

eddy current inspections for cracking of 

certain fastener rows, and contacting Airbus 

for repair instructions and repairing. 

Actions and Compliance 

(f) Unless already done, do the following 

actions. 

(1) For Airbus Model A330–300 and A340– 

300 series airplanes, except Model A340–300 

weight variant (WV) 027 airplanes: At the 

applicable compliance time specified in 

paragraph (f)(2) of this AD, perform a HFEC 

inspection of the upper shell structure 

between FR80 and FR86, in accordance with 

the Accomplishment Instructions of Airbus 

Mandatory Service Bulletin A330–53–3168 

or A340–53–4174, both Revision 01, both 

dated February 15, 2008, as applicable. 

(i) If no crack is detected, repeat the 

inspection thereafter within the intervals 

specified in paragraph 1.E.(2) of Airbus 

Mandatory Service Bulletin A330–53–3168 

or A340–53–4174, both Revision 01, both 

dated February 15, 2008, as applicable. 

(ii) If any crack is detected during any 

inspection required by this AD: Before next 

flight, contact Airbus for repair instructions 

and do applicable repairs. 

(iii) Doing the modification of the upper 

shell structure in accordance with Airbus 

Service Bulletin A330–53–3159 or A340–53– 

4165, both dated September 19, 2007, as 

applicable, ends the inspections required by 

paragraph (f)(1) of this AD. 

(2) Do the actions required by paragraph 

(f)(1) of this AD at the later of the compliance 

times specified in paragraph (f)(2)(i) and 

(f)(2)(ii) of this AD. 

(i) Within the compliance times specified 

in paragraph 1.E.(2) of Airbus Mandatory 

Service Bulletin A330–53–3168 or A340–53– 

4174, both Revision 01, both dated February 

15, 2008, as applicable. 

(ii) Within 3 months after the effective date 

of this AD. 

(3) At the applicable time specified in 

paragraphs (f)(3)(i), (f)(3)(ii), and (f)(3)(iii) of 

this AD or within 3 months after the effective 

date of this AD, whichever occurs later, 

modify the upper shell structure between 

FR80 and FR86 (including doing eddy 

current inspections for cracking of certain 

fastener rows and applicable corrective 

actions) in accordance with the 

Accomplishment Instructions of Airbus 

Mandatory Service Bulletin A330–53–3160, 

dated July 9, 2007; or Airbus Mandatory 

Service Bulletin A340–53–4172, dated July 

10, 2007; as applicable. Do all applicable 

corrective actions before further flight. 

(i) For Model A330–200 airplanes, WV 020 

through WV 027: Prior to the accumulation 

of 13,500 total flight cycles. 

(ii) For Model A330–200 airplanes, WV 

050 through WV 055: Prior to the 

accumulation of 10,700 total flight cycles or 

59,300 total flight hours, whichever occurs 

first. 

(iii) For Model A340–300 airplanes, WV 

027: Prior to the accumulation of 14,200 total 

flight cycles. 

(4) Inspections accomplished before the 

effective date of this AD according to Airbus 

Mandatory Service Bulletins A330–53–3168 

and A340–53–4174, both dated September 

19, 2007, as applicable, are considered 

acceptable for compliance with the 

corresponding actions specified in this AD. 

FAA AD Differences 

Note: This AD differs from the MCAI and/ 

or service information as follows: Although 

the MCAI allows further flight after cracks 

are found during compliance with the 

required action, this AD requires that you 

repair the crack(s) before further flight. 

Other FAA AD Provisions 

(g) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA, has the authority to 

approve AMOCs for this AD, if requested, 

using the procedures found in 14 CFR 39.19. 

Send information to ATTN: Vladimir 

Ulyanov, Aerospace Engineer, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA, 1601 Lind Avenue, SW., 

Renton, Washington 98057–3356; telephone 

(425) 227–1138; fax (425) 227–1149. Before 

using any approved AMOC on any airplane 

to which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act, 

the Office of Management and Budget (OMB) 

has approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(h) Refer to MCAI European Aviation 

Safety Agency Airworthiness Directive 2007– 

0284, dated November 12, 2007, and the 

service bulletins specified in Table 1 of this 

AD, for related information. 

TABLE 1—SERVICE INFORMATION

Airbus service information Revision Date 

Mandatory Service Bulletin A330–53–3160 .................................................................................... Original ...................... July 9, 2007. 

Mandatory Service Bulletin A330–53–3168 .................................................................................... 01 .............................. February 15, 2008. 

Mandatory Service Bulletin A340–53–4172 .................................................................................... Original ...................... July 10, 2007. 

Mandatory Service Bulletin A340–53–4174 .................................................................................... 01 .............................. February 15, 2008. 

Service Bulletin A330–53–3159 ...................................................................................................... Original ...................... September 19, 2007. 

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66750 Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations 

TABLE 1—SERVICE INFORMATION—Continued 

Airbus service information Revision Date 

Service Bulletin A340–53–4165 ...................................................................................................... Original ...................... September 19, 2007. 

Material Incorporated by Reference 

(i) You must use the service information 

specified in Table 2 of this AD to do the 

actions required by this AD, unless the AD 

specifies otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Airbus, 1 Rond Point 

Maurice Bellonte, 31707 Blagnac Cedex, 

France; telephone +33 5 61 93 33 33; Internet 

http://www.airbus.com. 

(3) You may review copies at the FAA, 

Transport Airplane Directorate, 1601 Lind 

Avenue, SW., Renton, Washington; or at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

(202) 741–6030, or go to: http:// 

www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

TABLE 2—MATERIAL INCORPORATED BY REFERENCE

Airbus service information Revision Date 

Mandatory Service Bulletin A330–53–3160 .................................................................................... Original ...................... July 9, 2007. 

Mandatory Service Bulletin A330–53–3168 .................................................................................... 01 .............................. February 15, 2008. 

Mandatory Service Bulletin A340–53–4172 .................................................................................... Original ...................... July 10, 2007. 

Mandatory Service Bulletin A340–53–4174 .................................................................................... 01 .............................. February 15, 2008. 

Service Bulletin A330–53–3159 ...................................................................................................... Original ...................... September 19, 2007. 

Service Bulletin A340–53–4165 ...................................................................................................... Original ...................... September 19, 2007. 

Issued in Renton, Washington, on October 

20, 2008. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E8–25787 Filed 11–10–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 17 

[Docket No. FDA–2008–N–0561] 

Maximum Civil Money Penalty 

Amounts and Compliance With the 

Federal Civil Penalties Inflation 

Adjustment Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a new 

regulation to adjust for inflation the 

maximum civil money penalty amounts 

for the various civil money penalty 

authorities within our jurisdiction. We 

are taking this action to comply with the 

Federal Civil Penalties Inflation 

Adjustment Act of 1990 (FCPIAA), as 

amended. The last adjustment was 

published in the Federal Register of 

July 20, 2004 (69 FR 43299), and the 

FCPIAA requires Federal agencies to 

adjust their civil money penalties at 

least once every 4 years. This rule does 

not adjust the civil money provisions 

enacted by the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA). We are using direct final 

rulemaking for this action because the 

agency expects that there will be no 

significant adverse comment on the 

rule. In the proposed rule section of this 

issue of the Federal Register, we are 

concurrently proposing and soliciting 

comments on this rule. If significant 

adverse comments are received, we will 

withdraw this final rule and address the 

comments in a subsequent final rule. 

FDA will not provide additional 

opportunity for comment. 

DATES: This rule is effective March 27, 

2009, without further notice, unless 

FDA receives significant adverse 

comment by January 26, 2009. If we 

receive no timely significant adverse 

comments, we will publish a document 

in the Federal Register before February 

25, 2009, confirming the effective date 

of the direct final rule. If we receive any 

timely significant adverse comments, 

we will publish a document in the 

Federal Register withdrawing this 

direct final rule before March 27, 2009. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N– 

0561, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described 

previously, in the ADDRESSES portion of 

this document under Electronic 

Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No. FDA–2008–N–0561 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Interested 

persons may submit to the Division of 

Dockets Management (see ADDRESSES) 

written or electronic comments 

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