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
25616 Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations

extension. The amended rules set forth

procedures that govern the content and

submission of applications for an

interim extension of a patent term, and

procedures governing the interim

extension determination and issuance of

interim patent term extension

certificates by the Office.

The initial guidelines directed to the

preparation and filing of applications

for interim extensions of patent terms as

authorized by 35 U.S.C. 156(d)(5), were

published as ‘‘Guidelines For Interim

Extension Under 35 U.S.C. 156(d)(5) of

a Patent Term Prior To Regulatory

Approval of a Product For Commercial

Marketing or Use—Public Law 103–179

(December 3, 1993)’’ in the Official

Gazette at 1159 Off. Gaz. Pat. Office 12

(February 1, 1994). The Final Rule

supplements these initial guidelines. To

the extent that they conflict with the

interim guidelines, the Final Rule

governs.

It is important to keep in mind the

distinction between an interim patent

term extension under section 156(e)(2)

and the interim patent term extension

provided for by 35 U.S.C. 156(d)(5),

under section 156(d)(5). The former

applies after regulatory approval has

occurred and is addressed in 37 CFR

1.760. Interim patent term extensions

under section 156(e)(2) are not affected

by the amendments to the rules. The

latter applies before regulatory approval

has occurred and is addressed in 37 CFR

1.780 and 1.790.

The eligibility criteria for obtaining an

interim extension under section

156(d)(5) are substantially the same as

for obtaining patent term extension

under section 156 after regulatory

approval has occurred. Under the

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

patent owner or its agent may submit an

application for an interim patent term

extension within six months, but not

later than 15 days, of the original

expiration date of the patent. At the

time the application is submitted, the

regulatory review period must have

advanced to the approval phase as

defined in section 156(g), but must not

have ended. For a new drug, for

example, the approval phase is defined

in section 156(g)(1)(B)(ii) as the period

beginning on the date a new drug

application was initially submitted for

the new drug under § 505 of the Federal

Food, Drug and Cosmetic Act.

The content of the application for

interim extension is the same as for an

application for patent term extension

following regulatory review, with

certain modifications necessitated by

the circumstances. For example, the

application for interim term extension

will not be required to contain

information about regulatory approval

since that event has not occurred. A fee

is required for each interim extension

application filed before regulatory

approval occurs—$400.00 for the initial

application for interim extension and

$200.00 for each supplementary

application for interim extension.

The processing of an application for

interim patent term extension under 35

U.S.C. 156(d)(5), will not require

transmission of a copy of the

application to the regulatory agency.

However, it is contemplated that the

Office will consult with the regulatory

agency, as it has been doing for the past

10 years under section 156, on the

question of eligibility for patent term

extension.

If the patent is eligible for extension

but for the fact that it is still under

regulatory review, the Office can extend

the patent term in one-year increments

not to exceed five years from the

expiration date. Any such extension

would terminate 60 days after market

approval. Before the 60-day period

expires, the patentee could submit an

application for patent term extension,

supplying any additional information

necessary to obtain any additional

extension available under section 156.

The interim extension of patent term

available under section 156(d)(5) cannot

exceed the extension from the original

patent that would be available after

regulatory approval. Thus, for example,

a patent that was subject to the two-year

extension limitation of section

156(g)(6)(C), could not obtain interim

extension beyond two years from the

original patent term expiration date.

However, after an interim extension

under section 156(d)(5) has been

granted, the amount of patent term

extension available after regulatory

review is controlled by either section

156(d)(5) or section 156(g)(6) (A) or (B).

In no case would the extension go

beyond five years from the original

expiration date of the patent. However,

for those situations falling under section

156(g)(6)(C), where regulatory approval

occurs within the two-year period after

the original expiration date of the

patent, the extension after approval is

measured from the date on which the

product receives permission for

commercial marketing or use. Section

156(d)(5)(E)(ii).

Review of recent applications for

patent term extension has revealed that

the provisions of 37 CFR 1.785(c) may

be read as being inconsistent with 35

U.S.C. 156. The statute further requires

that an application for patent term

extension be filed by the patent owner

or its agent. 35 U.S.C. 156(d)(1). The

statute further requires under section

156(d)(1)(D) a description of the

activities undertaken by the applicant

(i.e., the patent owner or its agent)

during the regulatory review period, and

specifies in section 156(d)(2)(B)(i) that

the lack of due diligence by the

applicant during the regulatory review

period may be taken into account. Given

these statutory requirements, the Office

has held that in order to be eligible for

patent term extension, the patent owner

or its agent must have undertaken the

activities that lead to regulatory

approval. If a patent owner has not been

involved, either directly or indirectly, in

the regulatory review process, that

patent owner has not lost any effective

patent life since it never invested time

and resources necessary to obtain

approval for commercial marketing or

use. Accordingly, to the extent that 37

CFR 1.785 could be interpreted to

permit a patent owner to obtain a patent

term extension where neither the patent

owner nor its agent were responsible for

activities leading to regulatory approval,

it was misleading and contrary to both

the letter and intent of section 156.

A notice of proposed rulemaking

relating to Amendment to Rules for

Extension of Patent Term was published

in the Federal Register, 59 FR 56015,

(November 10, 1994) and in the Official

Gazette, 1169 Off. Gaz. Pat. Office 33

(December 13, 1994). A sole comment

was received in response to this notice,

but no change has been made in the text

of the proposed amendments and

additions to the rules.

The comment was directed to the

proposed amendment to 37 CFR

1.785(c) when taken in light of 35 U.S.C.

156. The comment suggested that the

party in interest before the regulatory

agency (e.g., the Food and Drug

Administration) should be the party to

obtain a patent term extension, whether

that party is the patent owner or

licensee, and regardless of any ‘‘agency’’

relationship which may exist between

the two with respect to such regulatory

proceedings. This may be accomplished,

it was argued, by construing the term

‘‘applicant’’ in 35 U.S.C. 156(d)(1)(D)

and (d)(2)(B)(i) to mean the ‘‘applicant

for regulatory approval.’’

In response, it is clear that under 35

U.S.C. 156(a)(3) and (d)(1), the

‘‘applicant’’ for the patent term

extension shall be either the ‘‘owner of

record of the patent’’ or the party which

may be construed to be ‘‘its agent,’’

which requirement is repeated in 35

U.S.C. 156(d)(5)(A) and (d)(5)(C) with

regard to interim extensions. Indeed, to

hold otherwise in the manner suggested

in the comment would violate the plain

meaning of 35 U.S.C. 156(c)(1), which

requires that the patent term extension
Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations 25617

period be reduced by the time that the

‘‘applicant for patent extension did not

act with due diligence during such

period of the regulatory review period.’’

This section not only cites 35 U.S.C.

156(d)(2)(B) but also is consistent with

the required description of activities

undertaken during the applicable

regulatory period set forth in 35 U.S.C.

156(d)(1)(D). The statute thus

specifically requires that the application

for patent term extension contain a

description of the activities performed

by the patent owner or its agent before

the regulatory agency with regard to

such proceedings, 35 U.S.C.

156(d)(1)(D), and further specifies that

the lack of due diligence by the patent

owner or its agent during the regulatory

review period may be taken into

account, 35 U.S.C. 156(c)(1) and

(d)(2)(B)(i).

In addition to the constraints of the

statutory language, the comment fails to

identify any justification for granting a

term extension on a patent where the

patent owner has not, either directly or

indirectly, incurred either the

significant costs associated with

regulatory approval or any delay in the

commercial marketing of a product.

Since the patent term extension

provisions of section 156 are intended

to be remedial in nature, providing a

patent term extension to a patent owner

who has not been harmed by the delay

and costs associated with regulatory

approval of a product would provide an

unintended benefit to such a patent

owner. In addition, providing a patent

term extension to a patent owner that

did not participate in the regulatory

review process could also frustrate an

important purpose of the statute, that is,

to encourage companies to make the

significant investment necessary to

obtain regulatory approval and

distribute the pharmaceutical product to

the public rather than placing a nonparticipating patent owner in a position

to keep the product off the market

during the extended term, to the

detriment of the party that made the

significant investment necessary to

obtain regulatory approval.

Accordingly, not only does the plain

language of the statute prohibit the

statutory interpretation suggested in the

comment, but also the purpose of the

statute would not be fulfilled by

construing ‘‘applicant’’ to mean the

applicant for regulatory review.

Discussion of Specific Rules

Section 1.750 is being amended, as

proposed, to provide for an eligibility

determination which will be made on

applications for interim extension filed

in compliance with § 1.790. The section

is further modified to limit the mailing

of a notice of a final determination to

applications filed in compliance with

§ 1.740 after the regulatory approval

process is complete.

Section 1.750 is being amended, as

proposed, to require that the title recite

that the section is directed to requests

for interim extensions of patent term

under 35 U.S.C. 156(e)(2), to distinguish

in from interim extensions available

under 35 U.S.C. 156(d)(5), addressed in

§ 1.780.

Section 1.765(a) is being amended, as

proposed, to change the phrase (two

occurrences) ‘‘the Office of the

Secretary’’ to read ‘‘the Office or the

Secretary.’’ The change provides that

the applicant has a duty of disclosure to

both the Patent and Trademark Office

and the Secretary of Health and Human

Services or the Secretary of Agriculture.

Section 1.780 is being amended, as

proposed, to provide that a certificate of

interim extension under 35 U.S.C.

156(d)(5) will be issued to the applicant.

Section 1.780 also provides for

notification of the issuance of the

certificate of interim extension under 35

U.S.C. 156(d)(5), including the identity

of the product currently under

regulatory review, to be published in the

Federal Register.

Section 1.785 is being amended, as

proposed, to require the applicant for

extension, i.e., the patent owner or its

agent, to also have been the marketing

applicant who obtained regulatory

approval of the product for commercial

marketing or use. While regulatory

approval can be obtained by a party

other than the patent owner, that other

party must have been an agent of the

patent owner when obtaining the

regulatory approval in order for the

patent owner to be eligible to apply for

extension of the patent term.

Section 1.790 is being added, as

proposed, to provide for one or more

interim extensions for periods of up to

one year for patents where the

applicable regulatory review period

described in paragraph (1)(B)(ii),

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii)

of 35 U.S.C. 156(g) that began for the

patented product may extend beyond

the expiration of the patent term in

effect.

Paragraph (a) of added § 1.790 defines

the time periods in which the initial

interim extension application and each

subsequent interim extension

application must be filed in the Office.

In no event will interim extensions be

granted under proposed § 1.790 for a

period of extension longer than that to

which the applicant would be entitled

to under 35 U.S.C. 156(c).

Paragraph (b) of added § 1.790

establishes that the content

requirements for the initial interim

extension applications are substantially

the same as the content requirements for

a formal application for extension of

patent term under § 1.740 and a

complete application under § 1.741,

except that the content requirements

relate to a product currently undergoing

regulatory review. In other words, the

interim extension applications contain

information available to the patent

owner or its agent at the time the

application is filed.

Paragraph (c) of added § 1.790 permits

each interim extension application after

the initial interim extension application

to be limited to a request for a

subsequent interim extension along

with a statement that the regulatory

review period has not been completed

and any materials or information

required under §§ 1.740 and 1.741 not

present in the preceding interim

extension application.

Section 1.795 is being added, as

proposed, to provide that any interim

extension granted under 35 U.S.C.

156(d)(5) terminates at the end of the

60-day period beginning on the date on

which the product involved receives

permission for commercial marketing or

use. If within that 60-day period the

patent owner or its agent files additional

information required under 35 U.S.C.

156(d)(1) not contained in the

applications for interim extension, the

patent shall be further extended in

accordance with the provisions of 35

U.S.C. 156.

Other Considerations

These rule changes are in conformity

with the requirements of the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq.,

Executive Order 12612, and the

Paperwork Reduction Act of 1980, 44

U.S.C. 35091 et seq.

The Assistant General Counsel for

Legislation and Regulation of the

Department of Commerce has certified

to the Chief Counsel for Advocacy,

Small Business Administration, that

these rules will not have a significant

economic impact on a substantial

number of small entities (Regulatory

Flexibility Act, 5 U.S.C. 605(b)), because

the rules would affect only a very small

number of patents eligible for interim

patent term extension.

The Patent and Trademark Office has

also determined that this notice has no

Federalism implications affecting the

relationship between the National

Government and the States as outlined

in Executive Order 12612.

These rule changes contain collection

of information requirements subject to
25618 Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations

the Paperwork Reduction Act of 1980,

44 U.S.C. 35 U.S.C. 156(d)(5) 3501 et

seq., which have previously been

approved by the Office of Management

and Budget under Control Number

0651–0020. The public reporting burden

for this collection of information for

Petition Extension is estimated to

average 60 hours each, including the

time for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

the collections of information. Send

comments regarding this burden

estimate, or any other aspect of this

collection of information, including

suggestions for reducing the burden, to

Gerald A. Dost, Office of the Deputy

Assistant Commissioner for Patent

Policy and Projects, Box DAC,

Washington, DC 20231, and to the

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Washington, DC 20503 (ATTN:

Paperwork Reduction Act Projects

0651–0020).

List of Subjects in 37 CFR Part 1

Administrative practice and

procedure, Authority delegations

(government agencies), Conflict of

interest, Courts, Inventions and patents,

Lawyers.

For the reasons set forth, the

preamble, part 1 of title 37 of the Code

of Federal Regulations is amended to

read as follows:

PART 1—RULES OF PRACTICE IN

PATENT CASES

1. The authority citation for 37 CFR

part 1, subparts A and F continues to

read as follows:

Authority: 35 U.S.C. 6, unless otherwise

noted.

2. Section 1.20 is amended by revising

paragraph (j) to read as follows:

§ 1.20 Post-issuance fees.

* * * * *

(j) For filing an application for

extension of the term of a patent.

(1) Application for extension

under § 1.740 ........................ $1,030.00

(2) Initial application for interim extension under

§ 1.790 ................................... 400.00

(3) Subsequent application for

interim extension under

§ 1.790 ................................... 200.00

3. Section 1.750 is revised to read as

follows:

§ 1.750 Determination of eligibility for

extension of patent term.

A determination as to whether a

patent is eligible for extension may be

made by the Commissioner solely on the

basis of the representations contained in

the application for extension filed in

compliance with § 1.740 or § 1.790. This

determination may be delegated to

appropriate Patent and Trademark

Office officials and may be made at any

time before the certificate of extension

is issued. The Commissioner or other

appropriate officials may require from

applicant further information or make

such independent inquiries as desired

before a final determination is made on

whether a patent is eligible for

extension. In an application for

extension filed in compliance with

§ 1.740, a notice will be mailed to

applicant containing the determination

as to the eligibility of the patent for

extension and the period of time of the

extension, if any. This notice shall

constitute the final determination as to

the eligibility and any period of

extension of the patent. A single request

for reconsideration of a final

determination may be made if filed by

the applicant within such time as may

be set in the notice of final

determination or, if no time is set,

within one month from the date of the

final determination. The time periods

set forth herein are subject to the

provisions of § 1.136.

4. In § 1.760, the heading is revised to

read as follows:

§ 1.760 Interim extension of patent term

under 35 U.S.C. 156(e)(2).

5. Section 1.765(a) is revised to read

as follows:

§ 1.765 Duty of disclosure in patent term

extension proceedings.

(a) A duty of candor and good faith

toward the Patent and Trademark Office

and the Secretary of Health and Human

Services or the Secretary of Agriculture

rests on the patent owner or its agent,

on each attorney or agent who

represents the patent owner and on

every other individual who is

substantively involved on behalf of the

patent owner in a patent term extension

proceeding. All such individuals who

are aware, or become aware, of material

information adverse to a determination

of entitlement to the extension sought,

which has not been previously made of

record in the patent term extension

proceeding must bring such information

to the attention of the Office or the

Secretary, as appropriate, in accordance

with paragraph (b) of this section, as

soon as it is practical to do so after the

individual becomes aware of the

information. Information is material

where there is a substantial likelihood

that the Office or the Secretary would

consider it important in determinations

to be made in the patent term extension

proceeding.

6. Section 1.780 is revised to read as

follows:

§ 1.780 Certificate of extension of patent

term.

If a determination is made pursuant to

§ 1.750 that a patent is eligible for

extension and that the term of the patent

is to be extended, a certificate of

extension, under seal, or certificate of

interim extension under 35 U.S.C.

156(d)(5) will be issued to the applicant

for the extension of the patent term.

Such certificate will be recorded in the

official file of the patent and will be

considered as part of the original patent.

Notification of the issuance of the

certificate of extension will be

published in the Official Gazette of the

Patent and Trademark Office.

Notification of the issuance of the

certificate of interim extension under 35

U.S.C. 156(d)(5), including the identity

of the product currently under

regulatory review, will be published in

the Official Gazette of the Patent and

Trademark Office and in the Federal

Register. No certificate of extension will

be issued if the term of the patent

cannot be extended, even though the

patent is otherwise determined to be

eligible for extension. In such situations

the final determination made pursuant

to § 1.750 will indicate that no

certificate will issue.

7. Section 1.785 is revised to read as

follows:

§ 1.785 Multiple applications for extension

of term of the same patent or of different

patents for the same regulatory review

period for a product.

(a) Only one patent may be extended

for a regulatory review period for any

product (§ 1.720(h)). If more than one

application for extension of the same

patent is filed, the certificate of

extension of patent term, if appropriate,

will be issued based upon the first filed

application for extension.

(b) If more than one application for

extension is filed by a single applicant

which seeks the extension of the term of

two or more patents based upon the

same regulatory review period, and the

patents are otherwise eligible for

extension pursuant to the requirements

of this subpart, in the absence of an

election by the applicant, the certificate

of extension of patent term, if

appropriate, will be issued upon the

application for extension of the patent

term having the earliest date of issuance
Federal Register / Vol. 60, No. 92 / Friday, May 12, 1995 / Rules and Regulations 25619

of those patents for which extension is

sought.

(c) If an application for extension is

filed which seeks the extension of the

term of a patent based upon the same

regulatory review period as that relied

upon in one or more applications for

extension pursuant to the requirements

of this subpart, the certificate of

extension of patent term will be issued

on the application only if the patent

owner or its agent is the holder of the

regulatory approval granted with respect

to the regulatory review period.

(d) An application for extension shall

be considered complete and formal

regardless of whether it contains the

identification of the holder of the

regulatory approval granted with respect

to the regulatory review period. When

an application contains such

information, or is amended to contain

such information, it will be considered

in determining whether an application

is eligible for an extension under this

section. A request may be made of any

applicant to supply such information

within a non-extendable period of not

less than one (1) month whenever

multiple applications for extension of

more than one patent are received and

rely upon the same regulatory review

period. Failure to provide such

information within the period for

response set shall be regarded as

conclusively establishing that the

applicant is not the holder of the

regulatory approval.

(e) Determinations made under this

section shall be included in the notice

of final determination of eligibility for

extension of the patent term pursuant to

§ 1.750 and shall be regarded as part of

that determination.

8. Section 1.790 is added to read as

follows:

§ 1.790 Interim extension of patent term

under 35 U.S.C. 156(d)(5).

(a) An owner of record of a patent or

its agent who reasonably expects that

the applicable regulatory review period

described in paragraph (1)(B)(ii),

(2)(B)(ii), (3)(B)(ii), (4)(B) (ii), or

(5)(B)(ii) of subsection (g) that began for

a product that is the subject of such

patent may extend beyond the

expiration of the patent term in effect

may submit one or more applications for

interim extensions for periods of up to

one year each. The initial application

for interim extension must be filed

during the period beginning 6 months

and ending 15 days before the patent

term is due to expire. Each subsequent

application for interim extension must

be filed during the period beginning 60

days before and ending 30 days before

the expiration of the preceding interim

extension. In no event will the interim

extensions granted under this section be

longer than the maximum period of

extension to which the applicant would

be entitled under 35 U.S.C. 156(c).

(b) A complete application for interim

extension under this section shall

include all of the information required

for a formal application under § 1.740

and a complete application under

§ 1.741. Sections (a)(1), (a)(2), (a)(4), and

(a)(6)–(a)(17) of § 1.740 and § 1.741 shall

be read in the context of a product

currently undergoing regulatory review.

Sections (a)(3) and (a)(5) of § 1.740 are

not applicable to an application for

interim extension under this section.

(c) The content of each subsequent

interim extension application may be

limited to a request for a subsequent

interim extension along with a

statement that the regulatory review

period has not been completed along

with any materials or information

required under § 1.740 and § 1.741 that

are not present in the preceding interim

extension application.

9. Section 1.791 is added to read as

follows:

§ 1.791 Termination of interim extension

granted prior to regulatory approval of a

product for commercial marketing or use.

Any interim extension granted under

35 U.S.C. 156(d)(5) terminates at the end

of the 60-day period beginning on the

date on which the product involved

receives permission for commercial

marketing or use. If within that 60-day

period the patent owner or its agent files

an application for extension under

§ 1.740 and § 1.741 including any

additional information required under

35 U.S.C. 156(d)(1) not contained in the

application for interim extension, the

patent shall be further extended in

accordance with the provisions of 35

U.S.C. 156.

* * * * *

Dated: May 8, 1995.

Bruce A. Lehman,

Assistant Secretary of Commerce and

Commissioner of Patents and Trademarks.

[FR Doc. 95–11787 Filed 5–11–95; 8:45 am]

BILLING CODE 3510–16–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 261 and 302

[SWH–FRL–5206–4]

RIN 2050–AD59

Hazardous Waste Management

System; Carbamate Production

Identification and Listing of Hazardous

Waste; and CERCLA Hazardous

Substance Designation and Reportable

Quantities; Correction

AGENCY: Environmental Protection

Agency.

ACTION: Final rule; correction.

SUMMARY: The U.S. Environmental

Protection Agency (EPA) is correcting

minor errors in the amendments to the

regulations which appeared in the

Federal Register on April 17, 1995 (60

FR 19165).

EFFECTIVE DATE: August 9, 1995.

FOR FURTHER INFORMATION CONTACT: For

information concerning this notice,

please contact John Austin, Office of

Solid Waste (5304), U.S. Environmental

Protection Agency, 401 M Street SW.,

Washington, DC 20460, (202) 260–4789.

SUPPLEMENTARY INFORMATION: In the

February 9, 1995 final rule (60 FR 7824),

EPA designated a number of discarded

commercial chemical products, offspecification species, container

residues, and spill residues as

hazardous wastes. EPA subsequently

corrected typographical and omission

errors in the listing of these chemicals

in the notice of April 17, 1995 (60 FR

19165). Today EPA is correcting a typo

and an omission to the April document.

The correction notice incorrectly

states the Chemical Abstract Number

(CAS) for the substance Mexacarbate.

The correct CAS number is 315–18–4.

The correction notice also fails to

include the addition of the substance

sodium diethyldithiocarbamate to the

Appendix A list of the additions to

CERCLA Section 302.4 in numerical

sequence of their CAS Registry

numbers. The Agency is amending

Appendix A to § 302.4 to reflect the

additions to § 304.4 that were finalized

by the February 9, 1995 document.

Dated: May 8, 1995.

Elliott P. Laws,

Assistant Administrator, Office of Solid Waste

and Emergency Response.

Accordingly, the publication on April

17, 1995 of corrections to the final

regulations, which were the subject of

FR Doc. 95–2983, is corrected as

follows: