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. 

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Proposed Rules 68283

1OSHA also adopted under Section 6(a) a number 

of industry standards that were established Federal 

Standards or that were referenced in national 

consensus standards. For convenience only, this 

Continued

to CC:PA:LPD:PR (REG–138176–02), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC, or sent 

electronically, via the IRS Internet site 

at http://www.irs.gov/regs. or via the 

Federal eRulemaking Portal at http://

www.regulations.gov (IRS–REG–

138176–02).

FOR FURTHER INFORMATION CONTACT:

Concerning submissions of comments, 

the hearing, and/or to be placed on the 

building access list to attend the hearing 

Sonya M. Cruse, (202) 622–4693 (not a 

toll-free number).

SUPPLEMENTARY INFORMATION: The 

subject of the public hearing is the 

notice of proposed rulemaking (REG–

138176–02) that was published in the 

Federal Register on September 21, 2004 

(69 FR 56377). 

The rules of 26 CFR 601.601(a)(3) 

apply to the hearing. Persons who have 

submitted written comments and wish 

to present oral comments at the hearing 

must submit an outline of the topics to 

be discussed and the amount of time to 

be devoted to each topic (signed original 

and eight (8) copies) by December 28, 

2004. 

A period of 10 minutes is allotted to 

each person for presenting oral 

comments. After the deadline for 

receiving outlines has passed, the IRS 

will prepare an agenda containing the 

schedule of speakers. Copies of the 

agenda will be made available, free of 

charge, at the hearing. Because of access 

restrictions, the IRS will not admit 

visitors beyond the immediate entrance 

area more than 30 minutes before the 

hearing. For information about having 

your name placed on the building 

access list to attend the hearing, see the 

FOR FURTHER INFORMATION CONTACT

section of this document.

Cynthia E. Grigsby, 

Acting Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel, (Procedures and 

Administration).

[FR Doc. 04–26063 Filed 11–23–04; 8:45 am] 

BILLING CODE 4830–01–P

DEPARTMENT OF LABOR

Occupational Safety and Health 

Administration 

29 CFR Part 1910 

[Docket No. S–023] 

RIN 1218–AC08 

Updating OSHA Standards Based on 

National Consensus Standards

AGENCY: Occupational Safety and Health 

Administration (OSHA); Labor.

ACTION: Proposed rule; notice of project 

to update OSHA standards that are 

based on National Consensus Standards. 

SUMMARY: OSHA is engaging in an 

overall effort to update OSHA standards 

that reference, or that include language 

taken directly from, outdated consensus 

standards. The Agency adopted many of 

these standards over 30 years ago under 

Section 6(a) of the Occupational Safety 

and Health Act of 1970. Most of the 

referenced documents have been either 

superseded by later versions or 

withdrawn by the issuing Standards 

Development Organization (SDO). Many 

are no longer in print or available to the 

public through the issuing SDO. The 

outdated versions in the OSHA 

standards do not reflect advances in 

technologies that have changed 

workplace safety over the last 30 years. 

OSHA will use a variety of regulatory 

approaches to update these standards, 

including notice and comment 

rulemaking, direct final rulemaking, and 

technical amendments.

DATES: Comments to this notice must be 

submitted by the following dates: 

• Hard copy: Your comments must be 

submitted (postmarked or sent) by 

December 27, 2004. 

• Electronic transmission and 

facsimile: Your comments must be sent 

by December 27, 2004.

ADDRESSES: You may submit written 

comments on this notice—identified by 

docket number S–023 or RIN number 

1218–AC08—by any of the following 

methods: 

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• OSHA Web Site: http://

ecomments.osha.gov. Follow the 

instructions for submitting comments 

on OSHA’s Web page. 

• Fax: If your written comments are 

10 pages or fewer, you may fax them to 

the OSHA Docket Office at (202) 693–

1648. 

• Regular mail, express delivery, 

hand delivery, and courier service:

Submit three copies to the OSHA 

Docket Office, Docket No. S–023, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Room N–2625, 

Washington, DC 20210; telephone (202) 

693–2350. (OSHA’s TTY number is 

(877) 889–5627.) OSHA Docket Office 

hours of operation are 8:15 a.m. to 4:45 

p.m., EST. 

Instructions: All comments received 

will be posted without change to

http://dockets.osha.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received go to http://

dockets.osha.gov.

FOR FURTHER INFORMATION CONTACT: For 

general information and press inquiries 

contact George Shaw, Acting Director, 

OSHA Office of Communications, Room 

N–3647, U.S. Department of Labor, 200 

Constitution Avenue, NW., Washington, 

DC 20210; telephone: (202) 693–1999. 

For technical inquiries, contact Ted 

Twardowski, Directorate of Standards 

and Guidance, Room N–3609, OSHA, 

U.S. Department of Labor, 200 

Constitution Avenue, NW., Washington, 

DC 20210; telephone: (202) 693–2070 or 

fax (202) 693–1663. Copies of this 

Federal Register notice are available 

from the OSHA Office of Publications, 

Room N–3101, U.S. Department of 

Labor, 200 Constitution Avenue, NW., 

Washington, DC 20210; telephone: (202) 

693–1888. Electronic copies of this 

Federal Register notice, as well as news 

releases and other relevant documents, 

are available at OSHA’s Web page at 

http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background 

OSHA has used consensus standards 

extensively as a basis for its mandatory 

safety and health standards since the 

earliest days of the Occupational Safety 

and Health Act of 1970 (OSH Act), 29 

U.S.C. 651 et seq. Under Section 6(a) of 

the OSH Act, OSHA was given the 

authority for a period of 2 years to adopt 

both national consensus standards and 

established Federal standards as OSHA 

standards without following notice and 

comment rulemaking procedures. 29 

U.S.C 655(a). Congress provided this 

authority so that OSHA would have a 

mechanism to begin immediately 

protecting the Nation’s workers through 

mandatory standards. Using Section 

6(a), the Agency adopted many 

consensus standards as OSHA 

standards.1 OSHA adopted some of the