69276 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 

FDC Date State City Airport FDC No. Subject No. 

11/01/05 .... OH MARYSVILLE ......... UNION COUNTY .................................... 5/0174 NDB RWY 27, AMDT 5B. 

11/01/05 .... WA YAKIMA .................. YAKIMA AIR TERMINAL/MCALLISTER 

FIELD.

5/0181 ILS RWY 27, AMDT 26C. 

11/01/05 .... WA PORT ANGELES ... WILLIAM R. FAIRCHILD INTL ............... 5/0187 ILS–1 RWY 8, AMDT 1C. 

11/02/05 .... MN ALEXANDRIA ......... CHANDLER FIELD ................................. 5/0218 ILS OR LOC RWY 31, ORIG-A. 

10/27/05 .... TX AUSTIN .................. AUSTIN-BERGSTROM INTL .................. 5/9947 ILS OR LOC RWY 35L, AMDT 3A. 

11/02/05 .... OK ARDMORE ............. ARDMORE MUNI ................................... 5/0226 ILS RWY 31, AMDT 4A. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0232 ILS OR LOC RWY 36, AMDT 1C. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0233 RNAV (GPS) RWY 36, AMDT 1A. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0234 RADAR–1, AMDT 1C. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0235 ILS OR LOC RWY 18, AMDT 1F. 

11/02/05 .... SC MYRTLE BEACH ... MYRTLE BEACH INTL ........................... 5/0236 RNAV (GPS) RWY 18, 1C. 

[FR Doc. 05–22493 Filed 11–14–05; 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: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending 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 an 

environmental impact statement (EIS) is 

required. FDA is taking this action in 

accordance with the National 

Environmental Policy Act (NEPA). 

DATES: This rule is effective December 

15, 2005. 

FOR FURTHER INFORMATION CONTACT: Rosa 

M. Gilmore, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276–

2346. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In the Federal Register of November 

24, 2004 (69 FR 68280), FDA published 

a proposed rule (the November 2004 

proposed rule) to amend its regulation 

on environmental impact considerations 

to expand existing categorical 

exclusions to include approvals of 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 

EA nor an EIS is required. Interested 

persons were given until December 27, 

2004, to comment on the proposal. FDA 

received two comments on the proposed 

rule. 

II. Summary of Comments and FDA’s 

Response 

(Comment 1) One comment opposed 

FDA’s proposal to expand existing 

categorical exclusions to include 

approvals of HDEs and establishment of 

special controls on the basis that a more 

rigorous standard should be applied 

before approval of ‘‘dangerous devices.’’

(Response) This comment seemed to 

misunderstand the proposed rule. FDA 

is not excluding any products from the 

statutorily required safety review under 

the Federal Food, Drug, and Cosmetic 

Act. The rule excludes certain categories 

of actions from the need to prepare an 

EA or EIS under the NEPA. 

(Comment 2) This comment did not 

express an opinion on the proposed 

rule. 

III. Background and Regulatory 

Authorities 

NEPA requires all Federal agencies to 

assess the environmental impacts of its 

actions and to ensure that the interested 

and affected public is informed of 

environmental analyses. The Counsel 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. CEQ’s 

regulations implementing the 

procedural requirements of NEPA can 

be found at 40 CFR parts 1500 through 

1508 and FDA’s NEPA policies and 

procedures can be found at 21 CFR part 

25. 

CEQ’s and FDA’s regulations, 40 CFR 

1508.4 and 21 CFR 25.5(a)(1), 

respectively, define ‘‘categorical 

exclusion’’ to mean a category of actions 

which have been found by procedures 

adopted by the Federal agency not to 

individually or cumulatively have a 

significant effect on the human 

environment and for which, therefore, 

neither an EA nor an EIS is required. 

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. 

FDA published final regulations 

governing compliance with NEPA as 

implemented by the CEQ regulations in 

the Federal Register of July 29, 1997 (62 

FR 40570). The July 29, 1997, 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. 

IV. Summary of the Final Rule 

FDA received two comments on the 

proposed rule, however, neither 

comment related to the statutory and 

regulatory authority of that proposal. 

Therefore, the discussion of the 

statutory and regulatory authority set 

out in the preamble of the proposed rule 

(69 FR 68280 at 68281 through 68282) 

remains relevant to this final rule and 

will not be repeated here. 

A. Special Controls 

FDA is amending its environmental 

impact regulations under § 25.34 to 

include 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, classification or 

reclassification of a device, 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. FDA issues 

special controls in order to assure that 

class II devices provide a reasonable 

assurance of safety and effectiveness. 

Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 69277 

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. 

B. HDE 

FDA is amending § 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. FDA approves few HDEs, 

further limiting any potential 

environmental impact. FDA’s 

experience in reviewing HDEs has 

shown that no HDE reviewed thus far 

has had a significant environmental 

impact. 

V. Environmental Impact 

The agency has determined that under 

21 CFR 24.30(h) this 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 environmental impact statement 

is required. 

VI. Analysis of Impacts 

FDA has examined the impacts of the 

final 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 final rule is not a 

significant regulatory action under 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 this final rule provides 

for an exclusion from the requirement to 

prepare an EA or EIS and, as such, 

relieves a burden, the agency certifies 

that this final rule will not have a 

significant economic 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 finalizing ‘‘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 $115 

million, using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

VII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects 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. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VIII. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

List of Subjects in 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, 

21 CFR part 25 is 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 humanitarian device 

exemption under subpart H of part 814 

of this chapter. 

Dated: October 14, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22563 Filed 11–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Parts 4022 and 4044 

Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets 

in Single-Employer Plans; Interest 

Assumptions for Valuing and Paying 

Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: The Pension Benefit Guaranty 

Corporation’s regulations on Benefits 

Payable in Terminated Single-Employer 

Plans and Allocation of Assets in 

Single-Employer Plans prescribe interest 

assumptions for valuing and paying 

benefits under terminating singleemployer plans. This final rule amends 

the regulations to adopt interest 

assumptions for plans with valuation 

dates in December 2005. Interest 

assumptions are also published on the 

PBGC’s Web site (http://www.pbgc.gov). 

DATES: Effective December 1, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, Attorney, Legislative 

and Regulatory Department, Pension 

Benefit Guaranty Corporation, 1200 K 

Street, NW., Washington, DC 20005, 

202–326–4024. (TTY/TDD users may 

call the Federal relay service toll-free at 

1–800–877–8339 and ask to be 

connected to 202–326–4024.) 

SUPPLEMENTARY INFORMATION: The 

PBGC’s regulations prescribe actuarial 

assumptions—including interest 

assumptions—for valuing and paying 

plan benefits of terminating singleemployer plans covered by title IV of