Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42807 

TABLE 2—COMPLIANCE TIMES FOR REPETITIVE INSPECTION INTERVAL

Model Repetitive inspection interval 

A310–203, A310–204, A310-221, and A310–222 airplanes .................... Within 1,700 flight cycles or 3,500 flight hours, whichever occurs first. 

‘SR’ A310–304, A310–322, A310–324, and A310–325 short range airplanes.Within 1,600 flight cycles or 4,600 flight hours, whichever occurs first. 

‘LR’ A310–304, A310–322, A310-324, and A310–325 long range airplanes.Within 1,200 flight cycles or 6,100 flight hours, whichever occurs first. 

(4) If any crack is found during any 

inspection required by paragraph (f)(1) or 

(f)(3) of this AD, before further flight, repair 

in accordance with the Accomplishment 

Instructions of Airbus Mandatory Service 

Bulletin A310–57–2096, dated May 6, 2008. 

Instead, for previously repaired areas, 

continue the inspection in accordance with 

the procedures specified in paragraph (g) of 

this AD. 

(5) After each inspection required by this 

AD, submit an inspection report in 

accordance with Airbus Mandatory Service 

Bulletin A310–57–2096, dated May 6, 2008; 

at the times specified in paragraphs (f)(5)(i) 

or (f)(5)(ii) of this AD, as applicable. 

(i) If the inspection was done after the 

effective date of this AD: Submit the report 

within 30 days after the inspection. 

(ii) If the inspection was accomplished 

prior to the effective date of this AD: Submit 

the report within 30 days after the effective 

date of this AD. 

FAA AD Differences 

Note 1: This AD differs from the MCAI 

and/or service information as follows: No 

differences. 

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: 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 

principal maintenance inspector (PMI) or 

principal avionics inspector (PAI), as 

appropriate, or lacking a principal inspector, 

your local Flight Standards District Office. 

(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 2008– 

0211, dated December 4, 2008; and Airbus 

Mandatory Service Bulletin A310–57–2096, 

dated May 6, 2008, for related information. 

Issued in Renton, Washington, on August 

17, 2009. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E9–20352 Filed 8–24–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2009–0718; Directorate 

Identifier 2009–NM–025–AD] 

RIN 2120–AA64 

Airworthiness Directives; Boeing 

Model 747 Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for all 

Boeing Model 747 airplanes. This 

proposed AD would require one-time 

detailed and high frequency eddy 

current inspections for cracks in the 

wing and horizontal stabilizer side-ofbody joints and the fuselage skin 

circumferential splices, and repair if 

necessary. This proposed AD would 

also require, for certain airplanes, 

repetitive detailed inspections for cracks 

of the fuselage skin circumferential 

splices, and repair if necessary. This 

proposed AD results from Boeing 

analysis indicating that the wing and 

horizontal stabilizer side-of-body joints, 

and the fuselage skin circumferential 

splices are susceptible to fatigue 

cracking due to high cyclic loads on the 

airplane. We are proposing this AD to 

detect and correct fatigue cracking at 

multiple adjacent locations in the 

subject areas, which could connect to 

form large cracks and result in reduced 

structural integrity leading to rapid 

decompression and consequent loss of 

control of the airplane. 

DATES: We must receive comments on 

this proposed AD by October 9, 2009. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

For service information identified in 

this proposed AD, contact Boeing 

Commercial Airplanes, Attention: Data 

& Services Management, P.O. Box 3707, 

MC 2H–65, Seattle, Washington 98124– 

2207; telephone 206–544–5000, 

extension 1, fax 206–766–5680; e-mail 

me.boecom@boeing.com; Internet 

https://www.myboeingfleet.com. You 

may review copies of the referenced 

service information at the FAA, 

Transport Airplane Directorate, 1601 

Lind Avenue, SW., Renton, Washington. 

For information on the availability of 

this material at the FAA, call 425–227– 

1221 or 425–227–1152. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Management Facility between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The AD 

docket contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Office 

(telephone 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: Ivan 

Li, Aerospace Engineer, Airframe 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
42808 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 

Branch, ANM–120S, FAA, Seattle 

Aircraft Certification Office, 1601 Lind 

Avenue, SW., Renton, Washington 

98057–3356; telephone (425) 917–6437; 

fax (425) 917–6590. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2009–0718; Directorate Identifier 

2009–NM–025–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD because of those 

comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

Boeing analysis indicates that the 

wing and horizontal stabilizer side-ofbody joints and the fuselage skin 

circumferential splices on Model 747 

airplanes are susceptible to fatigue 

cracking due to high cyclic loads on the 

airplane. This condition, if not 

corrected, could result in reduced 

structural integrity leading to rapid 

decompression and consequent loss of 

control of the airplane. 

Related Rulemaking 

On March 24, 2004, we issued AD 

2004–07–22, amendment 39–13566 (69 

FR 18250, April 7, 2004), for all Boeing 

Model 747 series airplanes. (A 

correction of AD AD 2004–07–22 was 

issued on December 26, 2007 (73 FR 

1052, January 7, 2008), to clarify the AD 

applicability.) That AD supersedes two 

existing ADs which require that the 

maintenance inspection program be 

revised to include inspections that will 

give no less than the required damage 

tolerance rating for each structural 

significant item, and repair of cracked 

structure. That AD also requires 

additional and expanded inspections, 

and repair of cracked structure. That AD 

resulted from a structural re-evaluation 

that identified additional structural 

elements where, if damage were to 

occur, supplemental inspections may be 

required for timely detection of fatigue 

cracking. We issued that AD to ensure 

the continued structural integrity of the 

entire fleet of Model 747 series 

airplanes. 

On January 29, 2004, we issued AD 

2004–03–09, amendment 39–13453 (69 

FR 6542, February 11, 2004), for all 

Boeing Model 747–100, 747–100B, 747– 

100B SUD, 747–200B, 747–200F, 747– 

200C, 747–300, 747SR, and 747SP series 

airplanes. That AD requires repetitive 

inspections for discrepancies of the 

structure near and common to the upper 

chord and splice fittings of the rear spar 

of the wing, and repair if necessary. 

That AD also provides for an optional 

modification that, if accomplished, 

terminates the repetitive inspection 

requirement, but would necessitate 

eventual post-modification inspections. 

We issued that AD to find and fix 

fatigue cracking of structure near and 

common to the upper chord and splice 

fittings of the rear spar of the wing, 

which could result in loss of structural 

integrity of the airplane. 

Relevant Service Information 

We have reviewed Boeing Alert 

Service Bulletin 747–51A2060, dated 

October 30, 2008. The service bulletin 

describes procedures for one-time 

detailed and open-hole high frequency 

eddy current (HFEC) inspections for 

cracks in the wing side-of-body (SOB) 

joint upper and lower surfaces; one-time 

detailed and open-hole HFEC 

inspections for cracks in the horizontal 

stabilizer SOB joint; one-time surface 

and open-hole HFEC inspections for 

cracks of the fuselage skin 

circumferential splices; as applicable; 

and repair if necessary. The service 

bulletin also describes procedures, for 

certain airplanes, for repetitive detailed 

inspections for cracks of the fuselage 

skin circumferential splices. The service 

bulletin also allows surface HFEC 

inspections as an option for doing 

certain open-hole HFEC inspections for 

cracks in the horizontal stabilizer SOB 

joint surfaces. For airplanes on which 

any crack is found during any 

inspection, the procedures include 

reporting the crack finding to Boeing 

and contacting Boeing for repair data, 

and repairing before further flight. 

The compliance times for the 

inspections are as follows: 

• For Groups 1 through 5 airplanes, 

for the detailed inspection of the 

fuselage skin circumferential splices: 

Before the accumulation of 25,000 total 

flight cycles, or within 1 year after the 

date on the service bulletin, whichever 

occurs later. For airplanes on which no 

crack is found, the inspection is 

repeated within 6,000 flight cycles after 

the initial inspection, and thereafter at 

intervals not to exceed 6,000 flight 

cycles. 

• For Groups 1 through 3 airplanes, 

for the detailed and open-hole HFEC 

inspections of the wing SOB joint upper 

and lower surfaces; detailed and openhole HFEC inspections of the horizontal 

stabilizer SOB joint; and surface and 

open-hole HFEC inspections of the 

fuselage skin circumferential splices are 

to be done at the later of the following 

times: Before the accumulation of 

30,000 total flight cycles or 115,000 total 

flight hours (whichever occurs first), or 

within 1 year after the date on the 

service bulletin. The service bulletin 

also specifies that operators do not 

accomplish the inspections until the 

airplane has accumulated at least either 

28,500 total flight cycles or 110,000 total 

flight hours. 

• For Groups 4 through 6 airplanes 

for the detailed and open-hole HFEC 

inspections of the wing SOB joint upper 

and lower surfaces; detailed and openhole HFEC inspections of the horizontal 

stabilizer SOB joint; and surface and 

open-hole HFEC inspections of the 

fuselage skin circumferential splices are 

to be done at the later of the following 

times: Before the accumulation of 

30,000 total flight cycles or 135,000 total 

flight hours (whichever occurs first), or 

within 1 year after the date on the 

service bulletin. The service bulletin 

also specifies that operators should not 

accomplish the inspections until the 

airplane has accumulated at least either 

28,500 total flight cycles or 130,000 total 

flight hours. 

FAA’s Determination and Requirements 

of This Proposed AD 

We are proposing this AD because we 

evaluated all relevant information and 

determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. This proposed AD would 

require accomplishing the actions 

specified in the service information 

described previously, except as 

discussed under ‘‘Difference Between 

the Proposed AD and Service 

Information.’’ 

Difference Between the Proposed AD 

and Service Information 

The service bulletin specifies to 

contact the manufacturer for 

instructions on how to repair certain 

conditions, but this proposed AD would 

require repairing those conditions in 

one of the following ways: 

• Using a method that we approve; or 

• Using data that meet the 

certification basis of the airplane, and 

that have been approved by an 

Authorized Representative for the 

Boeing Commercial Airplanes 

Delegation Option Authorization 


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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42809 

Organization whom we have authorized 

to make those findings. 

Interim Action 

We consider this proposed AD 

interim action. If final action is later 

identified, we might consider further 

rulemaking then. 

Costs of Compliance 

We estimate that this proposed AD 

would affect 165 airplanes of U.S. 

registry. We also estimate that it would 

take 2,604 work-hours per product to 

comply with this proposed AD. The 

average labor rate is $80 per work-hour. 

Based on these figures, we estimate the 

cost of this proposed AD to the U.S. 

operators to be $34,372,800, or $208,320 

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 proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would 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 proposed regulation: 

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. 

You can find our regulatory 

evaluation and the estimated costs of 

compliance in the AD Docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

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: 

Boeing: Docket No. FAA–2009–0718; 

Directorate Identifier 2009–NM–025–AD. 

Comments Due Date 

(a) We must receive comments by October 

9, 2009. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to all Boeing Model 

747–100, 747–100B, 747–100B SUD, 747– 

200B, 747–200C, 747–200F, 747–300, 747– 

400, 747–400D, 747–400F, 747SR, and 747SP 

series airplanes, certificated in any category. 

Subject 

(d) Air Transport Association (ATA) of 

America Code 51: Standard practices/ 

structures. 

Unsafe Condition 

(e) This AD results from a Boeing analysis 

indicating that the wing and horizontal 

stabilizer side-of-body joints, and the 

fuselage skin circumferential splices are 

susceptible to fatigue cracking due to high 

cyclic loads on the airplane. The Federal 

Aviation Administration is issuing this AD to 

detect and correct fatigue cracking at 

multiple adjacent locations in the subject 

areas, which could connect to form large 

cracks and result in reduced structural 

integrity leading to rapid decompression and 

consequent loss of control of the airplane. 

Compliance 

(f) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Inspections and Repair if Necessary 

(g) Except as provided by paragraphs (h) 

and (i) of this AD: At the applicable times 

specified in paragraph 1.E. of Boeing Alert 

Service Bulletin 747–51A2060, dated October 

30, 2008, do one-time inspections for cracks 

in the wing and horizontal stabilizer side-ofbody joints, and the fuselage skin 

circumferential splices; do detailed 

inspections, as applicable, for cracks of the 

fuselage skin circumferential splices; and do 

all applicable repairs before further flight, in 

accordance with the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

747–51A2060, dated October 30, 2008, 

except as provided by paragraphs (j) and (k) 

of this AD. As applicable, repeat the detailed 

inspection for cracks of the fuselage skin 

circumferential splices, at the applicable 

times specified in paragraph 1.E. of Boeing 

Alert Service Bulletin 747–51A2060, dated 

October 30, 2008. 

Exceptions to Compliance Times 

(h) Where Boeing Alert Service Bulletin 

747–51A2060, dated October 30, 2008, 

specifies a compliance time after ‘‘* * * the 

date on this service bulletin,’’ this AD 

requires compliance within the specified 

compliance time after the effective date of 

this AD. 

(i) Where Note (a) of Table 2 of paragraph 

1.E. of Boeing Alert Service Bulletin 747– 

51A2060, dated October 30, 2008, specifies 

that if a certain modification was done then 

certain inspections may be deferred ‘‘until 

the post modification inspection period as 

given in Service Bulletin 747–57A2314,’’ this 

AD allows, for airplanes on which the 

modification specified in Boeing Service 

Bulletin 747–57A2314 has been done, 

deferring the inspections specified in Part 2 

of paragraph 3.B., of the Work Instructions of 

Boeing Alert Service Bulletin 747–51A2060, 

dated October 30, 2008, until the applicable 

post-modification inspection intervals 

required by paragraph (e) of AD 2004–03–09, 

amendment 39–13453. 

Exception to Part 4 Actions 

(j) For Group 6 airplanes identified in 

Boeing Alert Service Bulletin 747–51A2060, 

dated October 30, 2008: Do the inspections 

specified in Part 4 of paragraph 3.B. of the 

Work Instructions of Boeing Alert Service 

Bulletin 747–51A2060, dated October 30, 

2008, in accordance with the procedures 

specified in paragraph (m) of this AD. 

Exception to Corrective Actions 

(k) If any crack is found during any 

inspection required by this AD, and Boeing 

Alert Service Bulletin 747–51A2060, dated 

October 30, 2008, specifies to contact Boeing 

for appropriate action: Before further flight, 

repair using a method approved in 

accordance with the procedures specified in 

paragraph (m) of this AD. 

Reporting Requirement 

(l) At the applicable time specified in 

paragraph (l)(1) or (l)(2) of this AD, submit 

a report of positive and negative findings of 

cracks found during the inspection required 

by paragraph (g) of this AD to Boeing 

Commercial Airplane Group, P.O. Box 3707, 

Seattle, Washington 98124–2207. 

Alternatively, operators may submit reports 

to their Boeing field service representatives. 

The report must contain, as a minimum, the 

following information: airplane serial 

number, flight cycles at time of discovery, 

location(s) and extent of positive crack 

findings. Under the provisions of the 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
42810 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 

Paperwork Reduction Act (44 U.S.C. 3501 et 

seq.), the Office of Management and Budget 

(OMB) has approved the information 

collection requirements contained in this AD 

and has assigned OMB Control Number 

2120–0056. 

(1) If the inspection was done on or before 

the effective date of this AD: Send the report 

within 30 days after the effective date of this 

AD. 

(2) If the inspection was done after the 

effective date of this AD: Send the report 

within 30 days after the inspection is done. 

Alternative Methods of Compliance 

(AMOCs) 

(m)(1) The Manager, Seattle Aircraft 

Certification Office (ACO), 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: Ivan 

Li, Aerospace Engineer, Airframe Branch, 

ANM–120S, FAA, Seattle ACO, 1601 Lind 

Avenue, SW., Renton, Washington 98057– 

3356; telephone (425) 917–6437; fax (425) 

917–6590; Or, e-mail information to 9–ANM– 

Seattle–ACO–AMOC–Requests@faa.gov. 

(2) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Before using any approved AMOC on 

any airplane to which the AMOC applies, 

notify your principal maintenance inspector 

(PMI) or principal avionics inspector (PAI), 

as appropriate, or lacking a principal 

inspector, your local Flight Standards District 

Office. The AMOC approval letter must 

specifically reference this AD. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Seattle ACO, to 

make those findings. For a repair method to 

be approved, the repair must meet the 

certification basis of the airplane, and the 

approval must specifically refer to this AD. 

Issued in Renton, Washington, on August 

7, 2009. 

Stephen P. Boyd, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. E9–20382 Filed 8–24–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0393] 

RIN 0910–AF86 

Medical Device Reporting: Electronic 

Submission Requirements 

Correction 

In proposed rule document E9–19683 

beginning on page 42203 in the issue of 

Friday, August 21, 2009 make the 

following correction: 

On page 42204, in the first column, 

under the DATES section, in the first line, 

‘‘November 19, 2009’’ should read 

‘‘Submit written or electronic comments 

on the proposed rule by November 19, 

2009’’. 

[FR Doc. Z9–19683 Filed 8–24–09; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2009–N–0344] 

Microbiology Devices; Reclassification 

of Herpes Simplex Virus Types 1 and 

2 Serological Assays 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its device classification 

regulations by correcting the regulation 

classifying herpes simplex virus (HSV) 

serological assays by removing the 

reference to HSV serological assays 

other than type 1 and type 2. When 

reclassifying this device, FDA 

mistakenly distinguished between HSV 

serological assays type 1 and type 2 and 

all other HSV serological assays. At that 

time, and today, the only 

preamendments HSV serological assays 

FDA was aware of were type 1 and type 

2, and therefore, the classification of 

HSV assays other than type 1 and type 

2 was incorrect. FDA is correcting the 

classification of this device to eliminate 

possible confusion resulting from this 

error. Elsewhere in this issue of the 

Federal Register, we are publishing a 

companion direct final rule. This 

proposed rule will provide a procedural 

framework to finalize the rule in the 

event we receive significant adverse 

comment and withdraw the direct final 

rule. 

DATES: Submit written or electronic 

comments by November 9, 2009. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2009–N– 

0344, 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, 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(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) 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. 

FOR FURTHER INFORMATION CONTACT: 

Scott McFarland, Center for Devices and 

Radiological Health WO/66, rm. 5543, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–6217. 

SUPPLEMENTARY INFORMATION: 

I. Why Is This Companion Proposed 

Rule Being Issued? 

This proposed rule is a companion to 

the direct final rule correcting 

§ 866.3305 (21 CFR 866.3305) by 

removing HSV serological assays other 

than type 1 and type 2 from the 

regulation. The direct final rule and this 

companion proposed rule are 

substantively identical. This companion 

proposed rule provides the procedural 

framework to finalize the rule in the 

event that the direct final rule receives 

any significant adverse comment and is 

withdrawn. We are publishing the direct 

final rule because we believe the rule is 

noncontroversial, and we do not 

anticipate receiving any significant 

adverse comments. If no significant 


jlentini on DSKJ8SOYB1PROD with PROPOSALS