Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68277

(ii) If the airload support roller travels 

beyond the limits specified in the service 

bulletin, repair in accordance with a method 

approved by the Manager, Seattle ACO, FAA 

or in accordance with data meeting the type 

certification basis of the airplane approved 

by a Boeing Company DER who has been 

authorized by the FAA to make such 

findings. 

(2) For Group III airplanes identified in the 

service bulletin: Modify the inboard 

jackscrews of the outboard flap (i.e., 

replacing the down stop at the inboard 

jackscrews of the outboard flap) in 

accordance with Part II of the 

Accomplishment Instructions of the service 

bulletin. 

(l) For Model 727 airplanes listed in Boeing 

Service Bulletin 57–72, dated September 21, 

1966: Before or at the same time with the 

requirements of paragraph (h) of this AD, do 

the actions specified in paragraphs (l)(1) 

through (l)(4) of this AD.

(1) Chamfer the upper and lower flanges at 

the aft end of the foreflap tracks in 

accordance with the Accomplishment 

Instructions of the service bulletin. 

(2) Do a standard magnetic particle 

inspection of the entire foreflap tracks for 

cracks in accordance with the 

Accomplishment Instructions of the service 

bulletin. If any crack is detected, before 

further flight, repair in accordance with a 

method approved by the Manager, Seattle 

ACO, FAA or in accordance with data 

meeting the type certification basis of the 

airplane approved by a Boeing Company DER 

who has been authorized by the FAA to make 

such findings. For a repair method to be 

approved, the approval must specifically 

reference this AD. 

(3) Do a general visual inspection of the 

track rib faces at the front and rear spars to 

verify if the opening in the spars is flush with 

or clear of the plane of the rib faces, in 

accordance with the Accomplishment 

Instructions of the service bulletin. If the 

opening is not flush or clear with the plane, 

before further flight, rework the spar opening 

in accordance with the Accomplishment 

Instructions of the service bulletin. 

(4) Do a general visual inspection of the 

head or shank of bolts by securing the 

foreflap links to the foreflap tracks to verify 

if they protrude beyond the edge of the track 

flange in accordance with the 

Accomplishment Instructions of the service 

bulletin. If the head or shank of the bolts 

protrude beyond the edge of the track flange, 

before further flight, rework in accordance 

with the Accomplishment Instructions of the 

service bulletin.

Note 1: For the purposes of this AD, a 

general visual inspection is defined as: ‘‘A 

visual examination of an interior or exterior 

area, installation, or assembly to detect 

obvious damage, failure, or irregularity. This 

level of inspection is made from within 

touching distance unless otherwise specified. 

A mirror may be necessary to enhance visual 

access to all exposed surfaces in the 

inspection area. This level of inspection is 

made under normally available lighting 

conditions such as daylight, hangar lighting, 

flashlight, or droplight and may require 

removal or opening of access panels or doors. 

Stands, ladders, or platforms may be required 

to gain proximity to the area being checked.’’

(m) For airplanes other than those 

identified in the service bulletins specified in 

paragraphs (j) through (l) of this AD: Before 

or at the same time with the requirements of 

paragraph (h) of this AD, do an inspection to 

verify if any of the parts listed in the ‘‘Spares 

Affected’’ paragraph of each service bulletin 

referenced in paragraphs (j) through (l) of this 

AD are installed on the airplane. If any part 

identified in that paragraph is found 

installed, before further flight, do the 

applicable corrective and investigative 

action(s) specified in paragraphs (j) through 

(l) of this AD. 

Optional Terminating Actions 

(n) Replacement of the two carriage attach 

fittings on the inboard and outboard foreflaps 

of each wing with new, improved fittings, in 

accordance with the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

727–57A0135, Revision 3, dated June 27, 

2002; and accomplishment of the actions 

specified in paragraphs (j) through (m) of this 

AD, as applicable, before or concurrently 

with the replacement; constitutes terminating 

action for the requirements of this AD. 

Optional Deferral of Inspection 

(o) Replacement of the two carriage attach 

fittings on the inboard and outboard foreflaps 

of each wing with new fittings having the 

same part number as the existing fittings, in 

accordance with the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

727–57A0135, Revision 3, dated June 27, 

2002; and accomplishment of the actions 

specified in paragraphs (j) through (m) of this 

AD, as applicable, before or concurrently 

with the replacement; defers the next 

inspection required by paragraph (f) of this 

AD for 10,000 flight cycles after the 

replacement. Thereafter, repeat the 

inspections required by paragraph (f) of this 

AD at intervals not to exceed 1,000 flight 

cycles. 

Credit for Previously Accomplished Service 

Bulletins 

(p) Installations accomplished before the 

effective date of this AD in accordance with 

Boeing Service Bulletin 57–59, dated 

September 2, 1965; are acceptable for 

compliance with the requirements of 

paragraph (j) of this AD. 

(q) Inspections and modifications 

accomplished before the effective date of this 

AD in accordance with Boeing Service 

Bulletin 727–27–133, dated October 7, 1971; 

are acceptable for compliance with the 

requirements of paragraph (k) of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(r)(1) In accordance with 14 CFR 39.19, the 

Manager, Seattle ACO, FAA, is authorized to 

approve alternative methods of compliance 

for this AD. 

(2) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by a 

Boeing Company Designated Engineering 

Representative who has been authorized by 

the Manager, Seattle ACO, to make those 

findings. For a repair method to be approved, 

the approval must specifically refer to this 

AD.

Issued in Renton, Washington, on 

November 19, 2004. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service.

[FR Doc. 04–26028 Filed 11–23–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2004–19678; Directorate 

Identifier 2004–NM–62–AD] 

RIN 2120–AA64 

Airworthiness Directives; Boeing 

Model 747–400F Series Airplanes

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The FAA proposes to adopt a 

new airworthiness directive (AD) for 

certain Boeing Model 747–400F series 

airplanes. This proposed AD would 

require initial detailed and open-hole 

high frequency eddy current inspections 

for cracking of the web, upper chord, 

and upper chord strap of the upper deck 

floor beams, and repair of any cracking. 

This proposed AD also would require a 

preventive modification of the upper 

deck floor beams, and repetitive 

inspections for cracking after 

accomplishing the modification. This 

proposed AD is prompted by reports of 

fatigue cracking found on the upper 

deck floor beam to frame attachment 

points. We are proposing this AD to 

prevent fatigue cracks in the upper 

chord, upper chord strap, and the web 

of the upper deck floor beams and 

resultant failure of the floor beams. 

Failure of a floor beam could result in 

damage to critical flight control cables 

and wire bundles that pass through the 

floor beam, and consequent loss of 

controllability of the airplane. Failure of 

the floor beam also could result in the 

failure of the adjacent fuselage frames 

and skin, and consequent rapid 

decompression of the airplane.

DATES: We must receive comments on 

this proposed AD by January 10, 2005.

ADDRESSES: Use one of the following 

addresses to submit comments on this 

proposed AD. 

• DOT Docket Web site: Go to

http://dms.dot.gov and follow the 

instructions for sending your comments 

electronically. 

68278 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

• Government-wide rulemaking Web 

site: Go to http://www.regulations.gov

and follow the instructions for sending 

your comments electronically. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street SW., Nassif Building, 

Room PL–401, Washington, DC 20590. 

• By fax: (202) 493–2251. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 Seventh Street SW., Washington, 

DC, 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, P.O. Box 3707, 

Seattle, Washington 98124–2207. 

You can examine the contents of this 

AD docket on the Internet at http://

dms.dot.gov, or at the Docket 

Management Facility, U.S. Department 

of Transportation, 400 Seventh Street 

SW., Room PL–401, on the plaza level 

of the Nassif Building, Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Technical information: Ivan Li, 

Aerospace Engineer, Airframe Branch, 

ANM–120S, FAA, Seattle Aircraft 

Certification Office, 1601 Lind Avenue, 

SW., Renton, Washington 98055–4056; 

telephone (425) 917–6437; fax (425) 

917–6590. 

Plain language information: Marcia 

Walters, marcia.walters@faa.gov.

SUPPLEMENTARY INFORMATION: 

Docket Management System (DMS) 

The FAA has implemented new 

procedures for maintaining AD dockets 

electronically. As of May 17, 2004, new 

AD actions are posted on DMS and 

assigned a docket number. We track 

each action and assign a corresponding 

directorate identifier. The DMS AD 

docket number is in the form ‘‘Docket 

No. FAA–2004–99999.’’ The Transport 

Airplane Directorate identifier is in the 

form ‘‘Directorate Identifier 2004–NM–

999–AD.’’ Each DMS AD docket also 

lists the directorate identifier (‘‘Old 

Docket Number’’) as a cross-reference 

for searching purposes. 

Comments Invited 

We invite you to submit any relevant 

written data, views, or arguments 

regarding this proposed AD. Send your 

comments to an address listed under 

ADDRESSES. Include ‘‘Docket No. FAA–

2004–19678; Directorate Identifier 

2004–NM–62–AD’’ in the subject line of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of the proposed AD. We will 

consider all comments submitted by the 

closing date and may amend the 

proposed AD in light of those 

comments. 

We will post all comments we 

receive, without change, to http://

dms.dot.gov, including any personal 

information you provide. We will also 

post a report summarizing each 

substantive verbal contact with FAA 

personnel concerning this proposed AD. 

Using the search function of that Web 

site, anyone can find and read the 

comments in any of our dockets, 

including the name of the individual 

who sent the comment (or signed the 

comment on behalf of an association, 

business, labor union, etc.). You can 

review DOT’s complete Privacy Act 

Statement in the Federal Register

published on April 11, 2000 (65 FR 

19477–78), or you can visit http://

dms.dot.gov.

We are reviewing the writing style we 

currently use in regulatory documents. 

We are interested in your comments on 

whether the style of this document is 

clear, and your suggestions to improve 

the clarity of our communications that 

affect you. You can get more 

information about plain language at 

http://www.faa.gov/language and http://

www.plainlanguage.gov.

Examining the Docket 

You can examine the AD docket on 

the Internet at http://dms.dot.gov, or in 

person at the Docket Management 

Facility office between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The Docket 

Management Facility office (telephone 

(800) 647–5227) is located on the plaza 

level of the Nassif Building at the DOT 

street address stated in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after the DMS 

receives them. 

Related Rulemaking 

On January 29, 2004, we issued AD 

2004–03–11, amendment 39–13455 (69 

FR 5920, February 9, 2004). That AD 

applies to certain Boeing Model 747–

200C and –200F series airplanes, and 

requires repetitive inspections to find 

fatigue cracking in the upper chord of 

the upper deck floor beams, and repair 

if necessary. For certain airplanes, that 

AD also provides an optional repair/

modification, which defers certain 

repetitive inspections. 

Actions Since Issuance of Previous 

Rulemaking 

Since issuance of AD 2004–03–11, we 

have received reports indicating that 

additional fatigue cracking was found 

on the upper deck floor beam to frame 

attachment points, on certain Model 

747–200F series airplanes. The upper 

deck floor beams on certain 747–400F 

series airplanes are similar to those on 

the affected 747–200F series airplanes. 

In light of these reports, we have 

determined that it is necessary to issue 

the proposed AD at this time to ensure 

the continued operating safety of the 

affected airplane fleet. Therefore, all of 

these models may be subject to the same 

unsafe condition. Failure of a floor beam 

due to fatigue cracking could result in 

damage to critical flight control cables 

and wire bundles that pass through the 

floor beam, and consequent loss of 

controllability of the airplane. Failure of 

the floor beam also could result in the 

failure of the adjacent fuselage frames 

and skin, and consequent rapid 

decompression of the airplane. 

Relevant Service Information 

We have reviewed Boeing Alert 

Service Bulletin 747–53A2443, dated 

May 9, 2002. The service bulletin 

describes procedures for a detailed 

inspection for cracking of the web, 

upper chord and upper chord strap of 

body stations 340 through 520 inclusive, 

of the upper deck floor beams; an openhole high frequency eddy current 

(HFEC) inspection for cracking of the 

fastener holes of the web, upper chord, 

and upper chord strap; and repair of any 

cracking. If any cracking is found, the 

procedures in the service bulletin 

include repairing the cracking and 

accomplishing a preventive 

modification before further flight, or 

contacting the manufacturer for repair 

instructions if the cracking exceeds 

certain limits. 

If no cracking is found, the 

procedures in the service bulletin 

include two options: Modifying the 

upper chord of the upper deck floor 

beams before further flight, or repeating 

the detailed and open-hole inspections 

before the accumulation of 20,000 total 

flight cycles, then accomplishing the 

preventive modification before further 

flight. Accomplishing the preventive 

modification extends the compliance 

time for the next detailed and open-hole 

or surface HFEC inspections of the 

upper deck floor beams to 15,000 flight 

cycles after accomplishing the 

modification. 

For the post-modification inspection, 

the service bulletin gives the option of 

either repeating the detailed and surface 

HFEC inspections every 1,000 flight 

cycles, or repeating the detailed and 

open-hole HFEC inspections every 5,000 

flight cycles. 

Accomplishing the actions specified 

in the service information is intended to 

adequately address the unsafe 

condition. 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68279

FAA’s Determination and Requirements 

of the Proposed AD 

We have evaluated all pertinent 

information and identified an unsafe 

condition that is likely to exist or 

develop on other airplanes of this same 

type design. Therefore, we are 

proposing this AD, which would require 

initial detailed and open-hole HFEC 

inspections for cracking of the web, 

upper chord, and upper chord strap of 

the upper deck floor beams, and repair 

of any cracking. The proposed AD also 

would require a preventive modification 

of the upper deck floor beams, and 

repetitive inspections for cracking after 

accomplishing the modification. The 

proposed AD would require you to use 

the service information described 

previously to perform these actions, 

except as discussed under ‘‘Differences 

Between the Alert Service Bulletin and 

This Proposed AD.’’

Differences Between the Alert Service 

Bulletin and This Proposed AD 

The service bulletin specifies that the 

manufacturer may be contacted for 

disposition of certain repair conditions, 

but this proposed AD would require the 

repair of those conditions to be 

accomplished in accordance with a 

method approved by the FAA, or in 

accordance with data meeting the type 

certification basis of the airplane 

approved by a Boeing Company 

Designated Engineering Representative 

who has been authorized by the FAA to 

make such findings. 

The service bulletin refers to a 

‘‘detailed visual inspection’’ for 

cracking of the web, upper chord, and 

strap of the upper deck floor beams. We 

have determined that the procedures in 

the service bulletin should be described 

as a ‘‘detailed inspection.’’ Note 1 has 

been included in this proposed AD to 

define this type of inspection. 

Although the service bulletin does not 

list a grace period in the compliance 

times for the initial inspections and the 

preventive modification, this proposal 

adds a grace period to those compliance 

times. We find that such a grace period 

will keep airplanes from being grounded 

unnecessarily.

Costs of Compliance 

This proposed AD would affect about 

53 airplanes worldwide and 13 

airplanes of U.S. registry. The following 

table provides the estimated costs for 

U.S. operators to comply with this 

proposed AD, depending on the 

airplane configuration:

ESTIMATED COSTS

Action Work hours 

Average 

labor rate 

per hour 

Parts Cost per airplane 

Number of 

affected 

U.S.-registered airplanes Fleet cost 

Pre-modification/inspections.11 .............................. $65 $0 .............................. $715 ........... 13 $9,295. 

Modification/Inspections 

done during modification.

498 or 524 ................. 65 13,554 or 14,874 ....... 45,924 or 

48,934.

13 597,012 or 636,142. 

Post-modification inspections.66 .............................. 65 0 ................................ 4,290, per 

inspection 

cycle.

13 55,770. 

Regulatory Findings 

We have 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 that the 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. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this proposed AD. See the ADDRESSES

section for a location to examine the 

regulatory evaluation.

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, 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 airworthiness 

directive (AD):

Boeing: Docket No. FAA–2004–19678; 

Directorate Identifier 2004–NM–62–AD.

Comments Due Date 

(a) The Federal Aviation Administration 

(FAA) must receive comments on this AD 

action by January 10, 2005. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Model 747–400F 

series airplanes, certificated in any category; 

as listed in Boeing Alert Service Bulletin 

747–53A2443, dated May 9, 2002. 

Unsafe Condition 

(d) This AD was prompted by reports of 

fatigue cracking found on the upper deck 

floor beam to frame attachment points. We 

are issuing this AD to prevent fatigue cracks 

in the upper chord, upper chord strap, and 

web of the upper deck floor beams and the 

resultant failure of the floor beams. Failure of 

a floor beam could result in damage to 

critical flight control cables and wire bundles 

that pass through the floor beam, and 

consequent loss of controllability of the 

airplane. Failure of the floor beam also could 

result in the failure of the adjacent fuselage 

frames and skin, and consequent rapid 

decompression of the airplane. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

68280 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

Service Bulletin Reference 

(f) For the purposes of this AD, the term 

‘‘service bulletin’’ means the 

Accomplishment Instructions of Boeing Alert 

Service Bulletin 747–53A2443, dated May 9, 

2002. 

Inspections/Repair/Modification 

(g) Before the accumulation of 15,000 total 

flight cycles, or within 1,000 flight cycles 

after the effective date of this AD, whichever 

is later: Accomplish detailed and open-hole 

high frequency eddy current (HFEC) 

inspections for cracking of the web, upper 

chord, and upper chord strap of the upper 

deck floor beams, by doing all the applicable 

actions in accordance with Part 3.B.1. of the 

service bulletin.

Note 1: For the purposes of this AD, a 

detailed inspection is: ‘‘An intensive 

examination of a specific item, installation, 

or assembly to detect damage, failure, or 

irregularity. Available lighting is normally 

supplemented with a direct source of good 

lighting at an intensity deemed appropriate. 

Inspection aids such as mirror, magnifying 

lenses, etc., may be necessary. Surface 

cleaning and elaborate procedures may be 

required.’’

(h) If any crack is found during any 

inspection required by paragraph (g) of this 

AD: Before further flight, accomplish the 

actions required by paragraph (h)(1) and 

(h)(2) of this AD. 

(1) Repair in accordance with the service 

bulletin; except where the service bulletin 

specifies to contact Boeing for appropriate 

action, before further flight, repair in 

accordance with a method approved by the 

Manager, Seattle Aircraft Certification Office 

(ACO), FAA; or according to data meeting the 

type certification basis of the airplane 

approved by a Boeing Company Designated 

Engineering Representative (DER) who has 

been authorized by the Manager, Seattle 

ACO, to make such findings. For a repair 

method to be approved by the Manager, 

Seattle ACO, as required by this paragraph, 

the Manager’s approval letter must 

specifically reference this AD. 

(2) Accomplish the inspections and 

preventive modification of the floor beams by 

doing all the actions in accordance with Part 

3.B.2. or Part 3.B.3. of the service bulletin, as 

applicable. If any crack is found during any 

inspection, before further flight, repair as 

required by paragraph (h)(1) of this AD. 

(i) If no crack is found during any 

inspection required by paragraph (g) of this 

AD: Accomplish the actions required by 

either paragraph (i)(1) or (i)(2) of this AD, at 

the time specified. 

(1) Before further flight: Accomplish the 

inspections and preventive modification of 

the floor beam by doing all the actions in 

accordance with Part 3.B.2 or Part 3.B.3. of 

the service bulletin, as applicable. If the 

preventive modification is performed 

concurrently with the inspections required 

by paragraph (g) of this AD, the upper chord 

straps must be removed when performing the 

open-hole HFEC inspection. If any crack is 

found during any inspection, before further 

flight, repair as required by paragraph (h)(1) 

of this AD. 

(2) Before the accumulation of 20,000 total 

flight cycles, or within 1,000 flight cycles 

after the effective date of this AD, whichever 

is later: Accomplish the inspections and 

preventive modification of the upper deck 

floor beams, by doing all the actions in 

accordance with Part 3.B.2. or 3.B.3. of the 

service bulletin, as applicable. If any crack is 

found during any inspection, before further 

flight, repair as required by paragraph (h)(1) 

of this AD. 

Post-Modification Inspections 

(j) Within 15,000 flight cycles after 

accomplishing the applicable preventive 

modification required by paragraph (h)(2), 

(i)(1), or (i)(2) of this AD: Accomplish the 

inspections required by either paragraph 

(j)(1) or (j)(2) of this AD; if any crack is found 

during any inspection, before further flight, 

repair as required by paragraph (h)(1) of this 

AD. 

(1) Accomplish detailed and surface HFEC 

inspections for cracking of the web, upper 

chord, and upper chord strap of the upper 

deck floor beams, by doing all the applicable 

actions in accordance with Part 3.B.4. of the 

service bulletin. If no crack is found, repeat 

the inspections at intervals not to exceed 

1,000 flight cycles. 

(2) Accomplish detailed and open-hole 

HFEC inspections for cracking of the web, 

upper chord, and strap of the upper deck 

floor beams, by doing all the applicable 

actions in accordance with Part 3.B.5. of the 

service bulletin. If no crack is found, repeat 

the inspections at intervals not to exceed 

5,000 flight cycles.

Note 2: There is no terminating action 

currently available for the repetitive 

inspections required by this AD.

Alternative Methods of Compliance 

(AMOCs) 

(k)(1) The Manager, Seattle ACO, has the 

authority to approve AMOCs for this AD, if 

requested in accordance with the procedures 

found in 14 CFR 39.19. 

(2) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by a 

Boeing Company DER who has been 

authorized by the Manager, Seattle ACO, to 

make those findings. For a repair method to 

be approved, the approval must specifically 

refer to this AD.

Issued in Renton, Washington, on 

November 10, 2004. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service.

[FR Doc. 04–26027 Filed 11–23–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 25

[Docket No. 2004N–0461]

Environmental Assessment; 

Categorical Exclusions

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulation on environmental 

impact considerations to expand 

existing categorical exclusions to 

include approvals of humanitarian 

device exemptions (HDEs) and 

establishment of special controls as 

categories of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment and for which neither an 

environmental assessment (EA) nor 

environmental impact statement (EIS) is 

required. Regulations issued by the 

Council on Environmental Quality 

require that all Federal Agencies assess 

the environmental impact of their major 

actions and ensure that the interested 

and affected public is informed of 

environmental analyses. FDA is taking 

this action in accordance with the 

National Environmental Policy Act 

(NEPA).

DATES: Submit written or electronic 

comments on the proposed rule by 

December 27, 2004. FDA proposes that 

any final regulation based on this 

proposal become effective 30 days after 

its date of publication in the Federal 

Register.

ADDRESSES: You may submit comments, 

identified by 2004N–0461, by any of the 

following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include [Docket No. 2004N–0461] in the 

subject line of your e-mail message.

• FAX: 301-827-6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852.

Instructions: All submissions received 

must include the agency name and 

Docket No(s). or Regulatory Information