76932 Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this rule will relieve a

burden and simplify the marketing of

these devices, the agency certifies that

the final rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

VI. Paperwork Reduction Act of 1995

FDA concludes that this final rule

contains no collections of information.

Therefore, clearance by the Office of

Management and Budget under the

Paperwork Reduction Act of 1995 is not

required.

VII. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rules 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 rules

does not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

List of Subjects in 21 CFR Part 876

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 876 is

amended as follows:

PART 876—GASTROENTEROLOGY—

UROLOGY DEVICES

1. The authority citation for 21 CFR

part 876 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 360l, 371.

2. Section 876.5980 is amended by

revising paragraph (b)(1) to read as

follows:

§ 876.5980 Gastrointestinal tube and

accessories.

* * * * *

(b) Classification. (1) Class II (special

controls). The barium enema retention

catheter and tip with or without a bag

that is a gastrointestinal tube and

accessory is exempt from the premarket

notification procedures in subpart E of

this part subject to the limitations in

§ 876.9.

* * * * *

Dated: December 3, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–31292 Filed 12–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8889]

RIN 1545–AV10

Guidance Regarding Claims for Certain

Income Tax Convention Benefits;

Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Correction to final regulations.

SUMMARY: This document contains

corrections to final regulations (TD

8889) which were published in the

Federal Register on Monday, July 3,

2000 (65 FR 40993). The final

regulations relate to claims for certain

income tax convention benefits.

DATES: This correction is effective July

3, 2000.

FOR FURTHER INFORMATION CONTACT:

Shawn R. Pringle (202) 622–3850 (not a

toll-free number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are subject

to these corrections are under section

894 of the Internal Revenue Code.

Need for Correction

As published, final regulations (TD

8889) contains errors that may prove to

be misleading and are in need of

clarification.

Correction of Publication

Accordingly, the publication of final

regulations (TD 8889),which was the

subject of FR Doc. 00–16761, is

corrected as follows:

1. On page 40996, column 2, in the

preamble under the paragraph heading

‘‘D. Treatment of Complex Trusts’’,

paragraph 2, line 13 from the bottom of

the paragraph, the language ‘‘the hands

of the interest holder are’’ is corrected

to read ‘‘the hands of the interest holder

are not’’.

2. One page 40997, column 1, in the

preamble under the paragraph heading

‘‘Special Analyses’’, paragraph 1, line 2,

the language ‘‘treasury decision not a

significant’’ is corrected to read

‘‘Treasury decision is not a significant’’.

§ 1.894–1 [Corrected]

3. On page 40997, column 1, correct

the amendatory instruction for Par. 2. to

read as follows:

Par. 2. Section 1.894–1 is amended as

follows:

1. Paragraph (d) is redesignated as

paragraph (e), and a new paragraph (d)

is added.

2. In newly designated paragraph (e),

add a sentence at the end of the

paragraph.

The additions read as follows:

4. On page 40999, column 2, § 1.894–

1(d)(5), paragraph (i) of Example 7., line

10, the language ‘‘legal personality of

the arrangement, A is not’’ is corrected

to read ‘‘legal personality in Country X

of the arrangement, A is not’’.

5. On page 40999, column 2, § 1.894–

1(d)(5), paragraph (i) of Example 7.,

lines 11 and 12, the language ‘‘liable to

tax at the entity level of Country X and

is not a resident within the meaning of’’

is corrected to read ‘‘liable to tax as a

person at the entity level in Country X

and is thus not a resident within the

meaning of’’.

6. On page 40999, column 2, § 1.894–

1(d)(5), paragraph (ii) of Example 7.,

line 9, the language ‘‘is not considered

a resident of Country X’’ is corrected to

read ‘‘is not considered a person in

Country X and thus not a resident of

Country X’’.

7. On page 40999, column 2, § 1.894–

1(d)(5), paragraph (ii) of Example 7.,

line 12, the language ‘‘derive the income

for purposes of the U.S.-’’ is corrected to

read ‘‘derive the income as a resident of

Country X for purposes of the U.S.-’’.

8. On page 41000, column 1, § 1.894–

1(d)(5), paragraph (i) of Example 11., the

last line of the paragraph, the language

‘‘subject to tax by Country X.’’ is

corrected to read ‘‘taxed by Country X.’’.

9. On page 41000, column 2, § 1.894–

1, after paragraph (d)(6), add a sentence

at the end of paragraph (e) to read as

follows:

§ 1.894–1 Income affected by treaty.

* * * * *

(e) * * * See paragraph (d)(6) of this

section for applicability dates for

paragraph (d) of this section.

10. On page 41000, column 2, a new

amendatory instruction Par. 3. is added

to read as follows:

Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations 76933

§ 1.894–1T [Removed]

Par. 3. Section 1.894–1T is removed.

Cynthia E. Grigsby,

Chief, Regulations Unit, Office of Special

Counsel (Modernization & Strategic

Planning).

[FR Doc. 00–31255 Filed 12–7–00; 8:45 am]

BILLING CODE 4830–01–U

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 250

RIN 1010–AC66

Oil and Gas and Sulphur Operations in

the Outer Continental Shelf—Update of

Documents Incorporated by

Reference—API Specification 14A,

Tenth Edition

AGENCY: Minerals Management Service

(MMS), Interior.

ACTION: Final rule.

SUMMARY: MMS is updating one

document incorporated by reference in

regulations governing oil and gas and

sulphur operations in the Outer

Continental Shelf (OCS). The new

edition of this document incorporated

by reference will ensure that lessees use

the best available and safest

technologies while operating in the

OCS. The updated document, issued by

the American Petroleum Institute (API),

is API Specification 14A, Tenth Edition,

November 2000, ISO 10432:1999,

Petroleum and natural gas industries—

Downhole equipment—Subsurface

safety valve equipment, Stock No.

G14A09.

DATES: This rule is effective January 8,

2001. The incorporation by reference of

publications listed in the regulation is

approved by the Director of the Federal

Register as of January 8, 2001.

FOR FURTHER INFORMATION CONTACT: Fred

Gray, Operations Analysis Branch, at

(703) 787–1027.

SUPPLEMENTARY INFORMATION: We use

standards, specifications, and

recommended practices developed by

standard-setting organizations and the

oil and gas industry for establishing

requirements for activities in the OCS.

This practice, known as incorporation

by reference, allows us to incorporate

the provisions of technical standards

into the regulations without increasing

the volume of the Code of Federal

Regulations (CFR). The legal effect of

incorporation by reference is that the

material is treated as if it was published

in the Federal Register. This material,

like any other properly issued

regulation, then has the force and effect

of law. We hold operators/lessees

accountable for complying with the

documents incorporated by reference in

our regulations. The regulations found

at 1 CFR part 51 govern how MMS and

other Federal agencies incorporate

various documents by reference.

Agencies can only incorporate by

reference through publication in the

Federal Register. Agencies must also

gain approval from the Director of the

Federal Register for each publication

incorporated by reference. Incorporation

by reference of a document or

publication is limited to the specific

edition or specific edition and

supplement or addendum cited in the

regulations.

The International Organization for

Standardization (ISO) is a worldwide

federation of national standards bodies

(ISO member bodies). Founded in the

mid-1940’s, ISO is a non-profit agency

based in Geneva, Switzerland, whose

purpose is to promote the development

of international standards and related

activities to facilitate the global

exchange of goods and services. The

American National Standards Institute

(ANSI) is the official United States

member body to ISO.

The work of preparing international

standards is normally carried out

through an ISO technical committee

(TC). Each member body interested in a

subject for which a TC has been

established has the right to be

represented on that committee. ANSI

relies on various United States trade and

industry associations, such as the API,

for support on industry-specific

standards. This standard was developed

by ISO/TC 67, ‘‘Materials, equipment

and offshore structures for petroleum

and natural gas industries.’’ API has

been appointed by ANSI to administer

the US ISO/TC 67 delegation, known as

the US Technical Advisory Group (US

TAG). MMS has been an active

participant in the US TAG since August

1998.

This second edition of the

international standard cancels and

replaces the first edition (ISO

10432:1993) and includes the changes

in the similar API standard, API

specification 14A, Ninth Edition, 1994,

and its supplement dated December 15,

1997. ISO 10432:1999 was released as a

Final Draft International Standard

(FDIS) on June 3, 1999. Voting to

advance the FDIS to a full international

standard occurred on August 3, 1999,

and the standard was published as an

international standard in November

1999.

ISO permits a national adoption of its

international standards with or without

the inclusion of regional-specific

annexes to account for regional or local

conditions. The API procedures to effect

the adoption of this international

standard with a regional annex included

a balloting and comment period to

ensure consensus among users,

manufacturers, regulatory agencies, and

other interested parties. API balloting of

the international standard with U.S.

annexes, including an annex addressing

the API quality specification and an

independent test agency, occurred on

June 9, 2000, and the API version of the

international standard was published in

October 2000.

This standard was formulated to

provide the minimum acceptable

requirements for subsurface safety valve

(SSSV) equipment—the SSSV is a

downhole safety device used to shut off

flow of oil and gas in the event of an

emergency. MMS views this important

piece of equipment as the last

opportunity to secure the well and/or

prevent pollution of the environment.

The standard covers SSSVs, safety valve

locks, safety valve landing nipples, and

all components that establish tolerances

and/or clearances that may affect

performance or interchangeability of the

SSSV equipment.

We currently incorporate by reference

the ninth edition (July 1994) of API

specification 14A, without Supplement

1. Until now, we have not included API

Specification 14A, Supplement 1, in the

documents incorporated by reference in

our regulations. Among other things,

API Specification 14A, Supplement 1,

deleted a 3-year requalification test

requirement for SSSVs.

We have been involved in a series of

meetings and discussions with oil and

gas operating companies,

representatives of oil and gas

associations, equipment manufacturers,

quality assurance auditors, independent

third-party testing and research

facilities, and MMS offshore inspectors

to consider the relative merits of the 3-

year requalification test requirement.

We specifically requested public

comment on the potential impacts of

deleting the 3-year requalification

testing requirement for SSSVs in the

Notice of Proposed Rulemaking (65 FR

9232) published in the Federal Register

on February 24, 2000. Comments were

also sought on the suitability of

including an international standard

among the documents incorporated by

reference in our regulations.

In response to our request for public

comment on the 3-year requalification

test requirement, we received five

comments supportive of deleting the 3-