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 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68281

Number (RIN) for this rulemaking. All 

comments received will be posted 

without change to http://www.fda.gov/

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, 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.fda.gov/ohrms/dockets/

default.htm 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: Rosa 

M. Gilmore, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–827–2970.

SUPPLEMENTARY INFORMATION:

I. National Environmental Policy Act

NEPA requires all Federal Agencies to 

assess the environmental impact of 

major actions and to ensure that the 

interested and affected public is 

informed of environmental analyses. 

The Council on Environmental Quality 

(CEQ) is responsible for overseeing 

Federal efforts to comply with NEPA. 

Both CEQ and FDA have issued 

regulations governing agency 

obligations and responsibilities under 

NEPA. In the Federal Register of March 

15, 1973 (38 FR 7001), FDA issued its 

first regulations to implement NEPA. 

FDA amended these regulations in the 

Federal Register of April 15, 1977 (42 

FR 19986), based on consideration of 

revised guidelines for preparing EISs 

issued by CEQ. In 1978, CEQ replaced 

its guidelines with regulations 

implementing the procedural 

requirements of NEPA (40 CFR parts 

1500 to 1508). To comply with CEQ 

regulations, in the Federal Register of 

April 26, 1985 (50 FR 16636), FDA 

revised its NEPA policies and 

procedures (part 25 (21 CFR part 25)).

The CEQ regulations, which are 

binding on all Federal executive 

agencies, establish procedures for 

implementing NEPA. Agencies may 

adopt procedures to supplement CEQ’s 

regulations. In adopting NEPAimplementing procedures, Federal 

Agencies are directed by CEQ to reduce 

paperwork (40 CFR 1500.4(p) and 

1500.2(b)) by using several means, 

including the use of categorical 

exclusions. Under the CEQ regulations, 

agencies are required to review their 

policies and procedures and, in 

consultation with CEQ, revise them as 

necessary to ensure full compliance 

with the purpose and provisions of 

NEPA (40 CFR 1507.3).

CEQ defines categorical exclusions as 

categories of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment and for which neither an 

EA nor an EIS is required (40 CFR 

1508.4). When categorically excluding 

an action, an agency must determine 

that there are no extraordinary 

circumstances related to the action that 

may result in the action having 

significant environmental effects.

In the Federal Register of July 29, 

1997 (62 FR 40570), FDA published 

final regulations governing compliance 

with NEPA as implemented by the CEQ 

regulations. The final rule listed certain 

device actions as categories of actions 

that do not individually or cumulatively 

have a significant effect on the human 

environment and for which neither an 

EA nor an EIS is required.

II. Special Controls

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 

(SMDA) (Public Law 101–629), the Food 

and Drug Administration Modernization 

Act (FDAMA) (Public Law 105–115), 

and the Medical Device User Fee and 

Modernization Act (Public Law 107–

250) established a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the act (21 U.S.C. 360c) 

established three classes of devices that 

receive varying levels of regulation, 

depending on the regulatory controls 

needed to provide reasonable assurance 

of their safety and effectiveness. Class II 

devices are those for which general 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but for which 

there is sufficient information to 

establish special controls to provide 

such assurance, including performance 

standards, post market surveillance, 

patient registries, development and 

dissemination of guidelines, 

recommendations, and other 

appropriate actions the agency deems 

necessary (section 513(a)(1)(B) of the 

act).

Prior to SMDA, the statutory 

definition of class II contemplated only 

the establishment of mandatory 

performance standards under section 

514 of the act (21 U.S.C. 360d). The 

SMDA, however, broadened the 

definition of a class II device to provide 

options in addition to the establishment 

of a performance standard. Consistent 

with the pre-SMDA definition of a class 

II device, FDA had categorically 

excluded issuance, amendment, or 

repeal of a standard for a class II device 

(§ 25.34(c)). Because the agency may 

now establish special controls that 

include options in addition to 

mandatory performance standards, FDA 

is proposing to amend its environmental 

impact regulation under § 25.34 to 

expand the existing categorical 

exclusions. FDA proposes to include 

issue, amendment, or repeal of a rule 

related to the establishment of any 

special control, if it will not result in an 

increase in the existing levels of use or 

changes in the intended use of a device 

or its substitutes.

Generally, FDA issues special controls 

in order to assure that class II devices 

provide a reasonable assurance of safety 

and effectiveness. The categorical 

exclusion does not apply if the action 

will result in increases in the existing 

levels of use of the device or changes in 

the intended use of the device or its 

substitutes. Under these conditions, 

FDA believes that it is appropriate to 

categorically exclude the establishment 

of a special control from the 

requirement to prepare an EA or EIS.

III. Humanitarian Device Exemption

The SMDA added section 520(m) to 

the act (21 U.S.C. 360j(m)) to encourage 

the development of devices intended for 

use in the treatment or diagnosis of 

diseases or conditions that affect or are 

manifested in fewer than 4,000 

individuals in the United States 

(humanitarian use devices). 

Accordingly, section 520(m) of the act 

authorizes FDA to exempt humanitarian 

use devices from the ‘‘effectiveness 

requirements’’ of sections 514 and 515 

of the act (21 U.S.C. 360e) (i.e., 

‘‘reasonable assurance that the device is 

effective’’). FDA may grant such an 

exemption provided that the following 

occurs: (1) The device is designed to 

treat or diagnose a disease or condition 

that affects fewer that 4,000 individuals 

in the United States; (2) the device 

would not be available to a person with 

such disease or condition unless the 

exemption is granted; (3) no comparable 

device (other than the device that has 

been granted such an exemption) is 

available to treat or diagnose the disease 

or condition; and (4) the device will not 

expose patients to an unreasonable or 

significant risk of illness or injury, and 

the probable benefit to health from 

68282 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 

using the device outweighs the risk of 

injury or illness from its use, taking into 

account the probable risk and benefits of 

currently available devices or 

alternative forms of treatment.

There are two steps to obtaining 

approval of a humanitarian use device. 

First, the applicant must submit a 

request for humanitarian use device 

designation to FDA’s Office of Orphan 

Products Development (§ 814.100(c)(1) 

(21 CFR 814.100(c)(1))). Next, the 

applicant must submit an HDE 

application (§ 814.100(c)(2)). Approval 

of an HDE authorizes marketing of the 

device. Designation of a device as a 

humanitarian use device is not a ‘‘major 

federal action’’ subject to analysis under 

NEPA because it is a determination that 

a device is eligible to apply for HDE 

approval and is not a final 

determination that any particular device 

may be marketed. A determination that 

a device is eligible to apply for HDE 

approval cannot by itself affect the 

environment. (See Alliance for BioIntegrity v. Shalala, 116 F. Supp. 2d 

166, 174 (D.D.C. 2000)). 

FDA is proposing to amend § 25.34 to 

include approval of an HDE as a 

category of action that does not 

individually or cumulatively have a 

significant effect on the human 

environment and for which neither an 

EA nor EIS is required. Because 

humanitarian use devices are limited by 

definition to use for treating or 

diagnosing diseases or conditions 

affecting fewer than 4,000 individuals in 

the United States per year, any 

environmental impact associated with 

use of a humanitarian use device is very 

limited. Additionally, FDA approves 

few HDEs (34 over the 7 years the 

program has been in effect), further 

limiting any potential environmental 

impact. Finally, FDA’s experience in 

reviewing HDEs has shown that no HDE 

reviewed thus far has had a significant 

environmental impact.

IV. Environmental Impact

The agency has determined under 21 

CFR 25.30(h) that this proposed action 

is of a type that does not individually 

or cumulatively have a significant effect 

on the human environment. Therefore, 

neither an environmental assessment 

nor an EIS is required.

V. Analysis of Impacts

FDA has examined the impacts of this 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this proposed rule is not a 

significant regulatory action as defined 

by the Executive order.

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the proposed rule 

provides for an exclusion from the 

requirement to prepare an EA or EIS 

and, as such, relieves a burden, the 

agency certifies that the proposed rule 

will not have significant impact on 

substantial number of small entities.

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $110 

million. FDA does not expect this 

proposed rule to result in any 1-year 

expenditure that would meet or exceed 

this amount.

VI. Paperwork Reduction Act of 1995

This proposed rule does not contain 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520).

List of Subjects

21 CFR Part 25

Environmental impact statements, 

Foreign relations, Reporting and 

recordkeeping requirements.

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of the Food and Drug Administration, it 

is proposed that 21 CFR part 25 be 

amended as follows:

PART 25—ENVIRONMENTAL IMPACT 

CONSIDERATIONS

1. The authority citation for 21 CFR 

part 25 continues to read as follows:

Authority: 21 U.S.C. 321–393; 42 U.S.C. 

262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR 

parts 1500–1508; E.O. 11514, 35 FR 4247, 3 

CFR, 1971 Comp., p. 531–533 as amended by 

E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., 

p. 123–124 and E.O. 12114, 44 FR 1957, 3 

CFR, 1980 Comp., p. 356–360.

2. Section 25.34 is amended by 

revising paragraph (b) and adding 

paragraph (i) to read as follows:

§ 25.34 Devices and electronic products.

* * * * *

(b) Classification or reclassification of 

a device under part 860 of this chapter, 

including the establishment of special 

controls, if the action will not result in 

increases in the existing levels of use of 

the device or changes in the intended 

use of the device or its substitutes.

* * * * *

(i) Approval of a humanitarian device 

exemption under subchapter H of part 

814 of this chapter.

Dated: November 8, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25974 Filed 11–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Internal Revenue Service 

26 CFR Part 1 

[REG–138176–02] 

RIN 1545–BA99 

Timely Mailing Treated as Timely 

Filing; Hearing

AGENCY: Internal Revenue Service (IRS), 

Treasury.

ACTION: Notice of public hearing on 

proposed rulemaking. 

SUMMARY: This document contains a 

notice of public hearing on proposed 

regulations that would amend 

§ 301.7502–1(e) to provide that, other 

than direct proof of actual delivery, a 

registered or certified mail receipt is the 

only prima facie evidence of delivery of 

documents that have a filing deadline 

prescribed by the internal revenue laws.

DATES: The public hearing will be held 

on Tuesday, January 11, 2005, at 10 a.m. 

Outlines of topics to be discussed at the 

hearing must be received by December 

28, 2004.

ADDRESSES: The public hearing will be 

held in the IRS Auditorium, Internal 

Revenue Building, 1111 Constitution 

Avenue, NW., Washington, DC. Send 

submissions to CC:PA:LPD:PR (REG–

138176–02), room 5203, Internal 

Revenue Service, POB, 7604, Ben 

Franklin Station, Washington, DC 

20044. Submissions may be hand 

delivered Monday through Friday 

between the hours of 8 a.m. and 4 p.m.