25612 Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations

helicopters was published in the

Federal Register on June 22, 1994 (59

FR 32144). That action proposed to

require the removal and replacement of

the ring gear within certain time

intervals, and proposed to establish a

retirement life for the ring gear.

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. No

comments were received on the

proposal or the FAA’s determination of

the cost to the public. The FAA has

determined that air safety and the

public interest require the adoption of

the rule as proposed. Since the issuance

of the proposed rule, the FAA has

revised the average labor rate from $55

per work hour to $60 per work hour,

which increases the estimated cost

impact on operators to $486,250.

The FAA estimates that 125

helicopters of U.S. registry will be

affected by this AD, that it will take

approximately 31.5 work hours per

helicopter to accomplish the required

actions, and that the average labor rate

is $60 per work hour. Required parts

will cost approximately $2,000 per

helicopter. Based on these figures, the

total cost impact of the AD on U.S.

operators is estimated to be $486,250.

The regulations adopted herein will

not 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. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under 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. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (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. App. 1354(a), 1421

and 1423; 49 U.S.C. 106(g); and 14 CFR

11.89.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive to

read as follows:

95–10–09 Sikorsky Aircraft: Amendment

39–9226. Docket No. 93–SW–18–AD.

Applicability: Model S–58 and S–58T

series helicopters, certificated in any

category.

Note 1: This AD applies to each helicopter

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (d) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To prevent failure of the transmission main

gear box ring gear (ring gear), failure of the

main transmission, and subsequent loss of

control of the helicopter, accomplish the

following:

(a) Within the next 25 hours time-inservice (TIS) after the effective date of this

AD, accomplish the following:

(1) From component records, determine the

TIS for the ring gear, part number (P/N)

S1635–20058–2.

(i) If the TIS on the ring gear is 2,400 or

more hours on the effective date of this AD,

replace it with an airworthy serialized ring

gear within the next 100 hours TIS.

(ii) If the TIS on the ring gear is less than

2,400 hours on the effective date of this AD,

replace it with an airworthy serialized ring

gear at or before reaching 2,500 hours TIS.

(2) If the TIS on the ring gear cannot be

determined, replace it in accordance with the

time-since-last-overhaul (TSO) as follows:

(i) If the TSO on the ring gear is 1,150 or

more hours on the effective date of this AD,

replace it with an airworthy serialized ring

gear within the next 100 hours TIS.

(ii) If the TSO on the ring gear is less than

1,150 hours on the effective date of this AD,

replace it with an airworthy serialized ring

gear at or before reaching 1,250 hours TSO.

(3) Create a component log and a serial

number and apply the serial number to the

ring gear between the ring gear flanges in

accordance with Paragraph B of the

Accomplishment Instructions of Sikorsky

Aircraft Alert Service Bulletin No. 58B35–32

(ASB 58B35–32), dated July 6, 1993.

(b) Create a component log and a serial

number for replacement ring gears and apply

the serial number to the ring gear between

the ring gear flanges in accordance with

Paragraph B of the Accomplishment

Instructions of the ASB 58B35–32, dated July

6, 1993, prior to installing a replacement ring

gear on the helicopter.

(c) This AD establishes a retirement life of

2,500 hours TIS for the ring gear. However,

for ring gears with 2,400 or more hours TIS,

or if the TIS cannot be determined, 1,150 or

more hours TSO on the effective date of this

AD, those ring gears need not be retired until

on or before the accumulation of an

additional 100 hours TIS.

(d) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used when approved by the Manager, Boston

Aircraft Certification Office, FAA. Operators

shall submit their requests through an FAA

Principal Maintenance Inspector, who may

concur or comment and then send it to the

Manager, Boston Aircraft Certification Office.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Boston Aircraft

Certification Office.

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the helicopter

to a location where the requirements of this

AD can be accomplished.

(f) The removal and replacement shall be

done in accordance with Sikorsky Aircraft

Alert Service Bulletin No. 58B35–32, dated

July 6, 1993. This incorporation by reference

was approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Sikorsky Aircraft, Commercial

Customer Support, 6900 Main Street,

Stratford, Connecticut 06601–1381. Copies

may be inspected at the FAA, Office of the

Assistant Chief Counsel, 2601 Meacham

Boulevard, Room 663, Fort Worth, Texas; or

at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(g) This amendment becomes effective on

June 16, 1995.

Issued in Fort Worth, Texas, on May 4,

1995.

Mark R. Schilling,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 95–11539 Filed 5–11–95; 8:45 am]

BILLING CODE 4910–13–P
Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations 25613

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 935

[OH–231; Amendment Number 68R]

Ohio Regulatory Program Amendment

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is announcing the

approval of a proposed amendment to

the Ohio regulatory program (hereinafter

referred to as the Ohio program) under

the Surface Mining Control and

Reclamation Act of 1977 (SMCRA). The

amendment was initiated by Ohio and

is intended to make the Ohio program

as effective as the corresponding Federal

regulations concerning

contemporaneous reclamation.

Specifically, the amendment defines the

terms ‘‘area mining,’’ ‘‘auger mining,’’

and ‘‘contour mining’’; specifies

information required in permit

operation plans and mining reclamation

plans; establishes time and distance

schedules for backfilling and grading for

mining methods other than area and

contour mining; and requires the

contemporaneous commencement of

augering.

EFFECTIVE DATE: May 12, 1995.

FOR FURTHER INFORMATION CONTACT:

Mr. Robert H. Mooney, Acting Director,

Columbus Field Office, Office of Surface

Mining Reclamation and Enforcement,

4480 Refugee Road, Suite 201,

Columbus, Ohio 43232; Telephone:

(614) 866–0578.

SUPPLEMENTARY INFORMATION:

I. Background on the Ohio Program.

II. Discussion of the Proposed Amendment.

III. Director’s Findings.

IV. Summary and Disposition of Comments.

V. Director’s Decision.

VI. Procedural Determinations.

I. Background on the Ohio Program

On August 16, 1982, the Secretary of

the Interior conditionally approved the

Ohio program. Information on the

general background of the Ohio

program, including the Secretary’s

findings, the disposition of comments,

and a detailed explanation of the

conditions of approval of the Ohio

program, can be found in the August 10,

1982, Federal Register (47 FR 34688).

Subsequent actions concerning the

conditions of approval and program

amendments are identified at 30 CFR

935.11, 935.15, and 935.16.

II. Discussion of the Proposed

Amendment

By letter dated May 17, 1994

(Administrative Record No. OH–2018),

the Ohio Department of Natural

Resources, Division of Reclamation

(Ohio), submitted proposed Program

Amendment Number 68 (PA 68). In this

amendment, Ohio proposed to revise

three rules in the Ohio Administrative

Code (OAC) at 1501:13–1–02, 1501:13–

4–05, and 1501:13–9–13 to make the

Ohio program as effective as the Federal

regulations concerning

contemporaneous reclamation. As part

of and in support of proposed PA 68,

Ohio also submitted a draft Policy/

Procedure Directive (PPD) which

provides additional clarification and

guidance on the proposed Ohio rule

requirements for contemporaneous

reclamation.

OSM announced receipt of the

proposed amendment in the May 26,

1994, Federal Register (59 FR 27253),

and, in the same notice, opened the

public comment period and provided an

opportunity for a public hearing on the

adequacy of the proposed amendment.

The public comment period closed on

June 27, 1994.

OSM and Ohio staff met on August

22, 1994, to discuss OSM’s questions

and concerns about PA 68

(Administrative Record No. OH–2093).

In response to OSM’s August 22, 1994,

questions and comments, Ohio provided

Revised Program Amendment Number

68 (PA 68R) by letter dated March 1,

1995 (Administrative Record No. OH–

2094). In PA 68R, Ohio proposed further

changes to the three rules and to the

draft PPD. OSM announced its receipt of

PA 68R in the March 17, 1995, Federal

Register (60 FR 14400). The public

comment period ended on April 3,

1995.

III. Director’s Findings

Set forth below, pursuant to SMCRA

and the Federal regulations at 30 CFR

732.15 and 732.17, are the Director’s

findings concerning the proposed

amendment to the Ohio program. Only

substantive changes to Ohio’s rules and

the new Ohio PPD are discussed below.

Rule revisions which are not discussed

below concern paragraph notations or

editorial or nonsubstantive wording

changes intended to improve the clarity

and readability of the rules.

1. Area Mining

Ohio is adding new OAC section

1501:13–1–02 paragraph (J) to define the

term ‘‘area mining’’ to mean a method

of surface coal mining that involves

making a series of parallel mining cuts

against the highwall created from the

initial mining cut. Although there is no

counterpart Federal definition for this

term, the Director finds that the

proposed definition is not inconsistent

with the requirements of SMCRA and

the Federal regulations.

2. Auger Mining

Ohio is revising its definition of the

term ‘‘auger mining’’ in OAC section

1501:13–1–02 paragraph (K) to mean

drilling holes or cutting into an exposed

coal seam at a highwall and transporting

the coal to the surface along an auger

bit, by conveyor, or by other means. The

Director finds that this definition is no

less effective than the corresponding

Federal definition of ‘‘auger mining’’ at

30 CFR 701.5.

3. Contour Mining

Ohio is adding new OAC section

1501:13–1–02 paragraph (CC) to define

the term ‘‘contour mining’’ to mean a

method of surface coal mining that

involves making an initial mining cut

along the contour of a hillside to the

maximum highwall height and then

making subsequent cuts along the same

contour, placing the spoil in the

preceding cut where the coal has been

removed. Although there is no

counterpart Federal definition for this

term, the Director finds that the

proposed definition is not inconsistent

with the requirements of SMCRA and

the Federal regulations.

4. Permit Operation Plan

Ohio is adding new OAC section

1501:13–4–05 paragraphs (A)(2)(a) (i)

through (iv) to require that the mining

operation plan in permit applications

shall, at a minimum, identify the mining

method to be used, the maximum extent

of cover to be mined, the locations

where mining will begin and end, and

the direction of mining. For mining

methods other than area or contour

mining, the mining operation plan shall

also include other information that

demonstrates the orderly and reasonable

progression of mining. Such information

shall include, but not be limited to,

spoil placement plans, proposed

locations of haul roads, and the

intended timing of the mining

operation. Mining operation plans shall

specify how the mining operation will

meet the time and distance

requirements for contemporaneous

reclamation established in OAC section

1501:13–9–13.

Ohio’s existing rule at OAC section

1501:13–4–05 paragraph (A)(2)(a) is

substantively identical to the

corresponding Federal regulation at 30

CFR 780.11(a) concerning the general
25614 Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations

requirements for mining operation

plans. Although there are no

corresponding Federal regulations to the

new requirements proposed in OAC

section 1501:13–4–05 paragraphs

(A)(2)(a) (i) through (iv), the Director

finds that these new requirements are

reasonable and are not inconsistent with

the Federal regulations at 30 CFR

780.11(a) and with the revisions which

Ohio is making elsewhere in this rule

and in other rules.

5. Mining Reclamation Plan

Ohio is revising OAC section

1501:13–4–05 paragraph (D)(2)(a) to

require that reclamation plans in permit

applications shall contain a detailed

timetable for the completion of each

major step of the reclamation plan

specific to the described mining method

and addressing the contemporaneous

reclamation requirements of OAC

section 1501:13–9–13.

Ohio’s existing rule at OAC section

1501:13–4–05 paragraph (D)(2)(a) is

substantively identical to the

corresponding Federal regulation at 30

CFR 780.18(b)(1) concerning the

timetable for completion of each major

step in the reclamation plan. Although

there are no corresponding Federal

regulations to the new requirements

proposed in OAC section 1501:13–4–05

paragraph (D)(2)(a), the Director finds

that these new requirements are

reasonable and are not inconsistent with

the Federal regulations at 30 CFR

780.18(b)(1) and with the revisions

which Ohio is making elsewhere in this

rule and in other rules.

6. Contemporaneous Reclamation

A. Ohio is revising OAC section

1501:13–9–13 paragraphs (A), (A)(1),

and (A)(2) and is adding new

paragraphs (A)(3) and (A)(4) to clarify

the rule language, to specify minimum

time and distance requirements for

backfilling and grading for mining

methods other than contour or area

mining, and to require the

contemporaneous commencement of

augering after the creation of the

highwall to be augered.

B. Ohio is adding new OAC section

1501:13–9–13 paragraph (A)(7) to clarify

that areas that are backfilled and rough

graded shall closely resemble the final

ground surface configuration approved

in the mining and reclamation plan but

that these areas are not necessarily

ready for resoiling or eligible for Phase

I bond release.

C. Ohio is supplementing the

requirements of OAC section 1501:13–

9–13 with proposed Policy/Procedure

Directive (PPD) Regulatory 94–3,

‘‘Contemporaneous Reclamation.’’ This

PPD provides clarification and guidance

on the requirements in the OAC for

contemporaneous reclamation.

The Federal regulations at 30 CFR

816/817.100 provide that reclamation

efforts shall occur as

contemporaneously as practicable

(except where a variance for concurrent

surface and underground mining is

issued under 30 CFR 785.18). However,

the Federal regulations have no

counterpart to the specific time and

distance requirements for

contemporaneous reclamation proposed

by Ohio in OAC section 1501:13–9–13

and in the accompanying PPD. On July

31, 1992 (57 FR 33876), OSM suspended

in full its specific backfilling and

grading time and distance requirements

at 30 CFR 816.101. In that notice of

suspension, OSM stated that mining

operations would continue to be subject

to the State-specific contemporaneous

reclamation regulations of State and

Federal programs which were then in

effect. OSM agreed that regulatory

authorities could set these State-specific

time and distance schedules based on

local conditions.

Therefore, there are no corresponding

Federal regulations to the new

requirements which Ohio has proposed

in OAC section 1501:13–9–13 and in the

new PPD. The Director finds that Ohio’s

new contemporaneous reclamation

requirements are reasonable and are not

inconsistent with the Federal

regulations at 30 CFR 816/817.100 and

with the revisions which Ohio is

making elsewhere in other rules.

IV. Summary and Disposition of

Comments

Public Comments

On May 26, 1994, and March 17,

1995, the Director solicited public

comments and provided an opportunity

for a public hearing on the proposed

amendment. OSM received comments

on the amendment from the Ohio

Mining and Reclamation Association

(OMRA) by letter dated April 1, 1995

(Administrative Record No. OH–2106).

OMRA made several objections to the

amendment:

(1) Ohio has not held a hearing on the

proposed rule changes. The Director

believes that this comment is not

immediately relevant to his decision on

this amendment. The public hearing

mentioned in the comment is part of

Ohio’s internal rule-filing process. If

further rule changes become necessary

as a result of comments received during

Ohio’s rule filing, Ohio will resubmit

those proposed changes to OSM for

review under the program amendment

process.

(2) The proposed rule changes do not

employ normal common sense relative

to contemporaneous reclamation in the

areas of weather, equipment failure, and

multiple seam mining. The time

constraints are too restrictive and could

result in Ohio issuing violations to mine

operators. The Director does not agree

with this comment. As discussed above,

the Director has reviewed Ohio’s

proposed reclamation schedules and

found them to be reasonable and not

inconsistent with the Federal

regulations at 30 CFR 816/817.100.

(3) The amendment seems to have

eliminated the difference between rough

and final grading. The Director does not

agree with this comment. The proposed

changes in the amendment concerning

backfilling and rough grading are not

inconsistent with the Federal

regulations at 30 CFR 816/817.100.

(4) The amendment reflects continued

overregulation and unreasonable

demands by the Federal government.

The Director does not agree with this

comment. As discussed above, OSM has

deliberately placed the responsibility for

developing contemporaneous

reclamation standards with the State

regulatory authorities most familiar with

the mining practices in their areas.

No other public comments were

received. No public hearings were held

as no one requested the opportunity to

provide testimony.

Agency Comments

Pursuant to 30 CFR 732.17(h)(11)(i),

the Director solicited comments on the

proposed amendment from the Regional

Director of the U.S. Environmental

Protection Agency (EPA) and the heads

of four other Federal agencies and one

State agency with an actual or potential

interest in the Ohio program.

Nonsubstantive comments were

received from the EPA, the Soil

Conservation Service, and the Mine

Safety and Health Administration. No

other agency comments were received.

V. Director’s Decision

Based on the above findings, the

Director approves the proposed

amendment as submitted by Ohio on

May 17, 1994, and revised on March 1,

1995.

The Federal regulations at 30 CFR

Part 935 codifying decisions concerning

the Ohio program are being amended to

implement this decision. This final rule

is being made effective immediately to

expedite the State program amendment

process and to encourage States to

conform their programs with the Federal

standards without undue delay.

Consistency of State and Federal

standards is required by SMCRA.
Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations 25615

Effect of Director’s Decision

Section 503 of SMCRA provides that

a State may not exercise jurisdiction

under SMCRA unless the State program

is approved by the Secretary. Similarly,

30 CFR 732.17(a) requires that any

alteration of an approved State program

be submitted to OSM for review as a

program amendment. Thus, any changes

to a State program are not enforceable

until approved by OSM. The Federal

regulations at 30 CFR 732.17(g) prohibit

any unilateral changes to approved

programs. In the oversight of the Ohio

program, the Director will recognize

only the approved program, together

with any consistent implementing

policies, directives, and other materials,

and will require the enforcement by

Ohio of such provisions.

VI. Procedural Determinations

Executive Order 12866

This final rule is exempted from

review by the Office of Management and

Budget (OMB) under Executive Order

12866 (Regulatory Planning and

Review).

Executive Order 12778

The Department of the Interior has

conducted the reviews required by

section 2 of Executive Order 12778

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15 and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination on whether

the submittal is consistent with SMCRA

and its implementing Federal

regulations and whether the other

requirements of 30 CFR Parts 730, 731,

and 732 have been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon corresponding Federal regulations

for which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

corresponding Federal regulations.

List of Subjects in 30 CFR Part 935

Intergovernmental relations, Surface

mining, Underground mining.

Dated: May 5, 1995.

Ronald C. Recker,

Acting Regional Director, Appalachian

Regional Coordinating Center.

For the reasons set out in the

preamble, Title 30, Chapter VII,

Subchapter T of the Code of Federal

regulations is amended as set forth

below:

PART 935—OHIO

1. The authority citation for Part 935

continues to read as follows:

Authority: 30 U.S.C. 1201 et seq.

2. Section 935.15 is amended by

adding new paragraph (www) to read as

follows:

§ 935.15 Approval of regulatory program

amendments.

* * * * *

(www) The following amendment

(Program Amendment 68R) pertaining

to the Ohio regulatory program, as

submitted to OSM on May 17, 1994, and

revised on March 1, 1995, is approved,

effective May 12, 1995:

Contemporaneous Reclamation.

[FR Doc. 95–11782 Filed 5–11–95; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. 950411099–5099–01]

RIN 0651–AA52

Amendment to Rules for Extension of

Patent Term

AGENCY: Patent and Trademark Office,

Commerce.

ACTION: Final rule.

SUMMARY: The Patent and Trademark

Office (Office) is revising the rules

directed to the extension of patent term

to implement the provisions of Pub. L.

103–179, section 5; 107 Stat. 2040

codified at 35 U.S.C. 156(d)(5) and to

clarify the requirements for eligibility.

The amended rules establish procedures

for the Commissioner to issue an

interim extension of the term of a patent

where the original term would expire

before a product covered by the patent

has received regulatory approval for

commercial marketing or use. The

amended rules also clarify that an

application for patent term extension

must be based on regulatory activities

performed by the patent owner or its

agent.

EFFECTIVE DATE: July 11, 1995.

FOR FURTHER INFORMATION CONTACT:

Gerald A. Dost by telephone at (703)

305–9285 or by mail addressed to

Commissioner of Patents and

Trademarks, Washington, DC 20231

marked to the attention of Mr. Dost,

Office of the Deputy Assistant

Commissioner for Patent Policy and

Projects, or by FAX to (703) 308–6916.

SUPPLEMENTARY INFORMATION: Patent

term extension has been available under

35 U.S.C. 156 for patents that claim

certain products that are subject to

regulatory review before being

commercially marketed or used. Prior to

enactment of 35 U.S.C. 156(d)(5),

eligibility for patent term extension was

dependent on regulatory approval of the

product before the original patent term

expired. 35 U.S.C. 156(d)(5) has made it

possible, under appropriate

circumstances, to obtain interim

extensions of patent term where the

regulatory process is likely to extend

beyond the expiration of the patent

term.

One purpose of the amended rules is

to revise the present regulations

contained in 37 CFR part 1, subpart F,

to include provisions for interim

extension of the patent term prior to

regulatory approval of the product that

can now form the basis of patent term