21090 Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Rules and Regulations

(b) For community development

purposes; and

(c) For administrative costs

reasonably related to the above.

Clearance Requirements

§ 183.11 What documents must the Tribe

submit to request money from the Lease

Fund?

To request a distribution of income

from the Lease Fund, the Tribe must

submit to us all of the following

documents:

(a) A certified copy of a duly enacted

resolution of the Tribal Council

requesting a distribution from the Lease

Fund;

(b) A pro forma budget for each

identified economic development

project and a program budget for each

identified community development

project, approved by the Tribal Council,

showing precisely how the Tribe will

spend the money;

(c) Supporting documentation for the

budgets required by paragraph (b) of this

section, and

(d) A certification stating that the

Tribe will use the funds in accordance

with budgets submitted under this

section.

§ 183.12 How long will it take to receive a

decision?

Within 30 days of receiving the

information required by § 183.11 we

will approve your request if it complies

with the Settlement Act and this part. If

we disapprove your request we will do

so in writing and will provide you with

the reasons for disapproval.

§ 183.13 What would cause the Secretary

to disapprove a request?

We will only disapprove a request for

distribution of income from the Lease

Fund if the request does any of the

following:

(a) Fails to provide the documents

identified in § 183.5;

(b) Fails to provide reports required

under §§ 183.15 and 183.16; or

(c) Includes a use requested or written

budget that does not comply with a

specific provision of the Settlement Act

or this part.

Limitations

§ 183.14 What limits are there on how the

Tribe can spend funds?

(a) The Tribe must spend income

distributed from the Lease Fund only in

accordance with a written budget

submitted under § 183.5.

(b) The Tribe must not spend the

income from the Lease Fund to make

per capita payments to members of the

Tribe.

Subpart D—Reports

§ 183.15 Must the Tribe submit any

reports?

Yes. The Tribe must submit the

following reports after receiving funds

under this part:

(a) An Annual Report, that must be

submitted no later than December 31 of

each year; and

(b) A Financial Audit, that must be

submitted no later than March 1 of each

year.

§ 183.16 What information must be

included in the Tribe’s annual report?

The Tribe’s annual report must

contain the following information:

(a) An accounting of the expenditures

of funds distributed to the Tribe from

the Trust Fund or the Lease Fund for the

preceding 12 months;

(b) A description, in detail, of how the

Tribe has used the funds distributed

from the Trust Fund or the Lease Fund

consistently with the requirements in

the Settlement Act, this part, and the

budget approved by the Tribal Council

and the Secretary; and

(c) Sufficient documentation for us to

determine that the Tribe has satisfied

the requirements of paragraph (b) of this

section.

Subpart E—Liability

§ 183.17 If expenditures under this part

lead to a claim or cause of action, who is

liable?

The Tribe may be liable. The United

States must not be liable for any claim

or cause of action arising from the

Tribe’s use or expenditure of monies

distributed from the Trust Fund or the

Lease Fund.

§ 183.18 Information Collection

Requirements

The information collection

requirements contained in this part do

not meet the requirements of ‘‘ten or

more persons’’ annually; therefore, the

Office of Management and Budget does

not need to clear the collection. You

may direct comments concerning this

information collection to the Bureau of

Indian Affairs, Information Collection

Control Officer, 1849 C Street, NW,

Washington, DC 20240.

Dated: April 19, 2001.

James H. McDivitt,

Deputy Assistant Secretary—Indian Affairs

(Management).

[FR Doc. 01–10250 Filed 4–26–01; 8:45 am]

BILLING CODE 4310–02–P

DEPARTMENT OF COMMERCE

United States Patent and Trademark

Office

37 CFR Part 1

[Docket No. 010208033–1033–01]

RIN 0651–AB33

Changes to the Time Period for Making

Any Necessary Deposit of Biological

Material

AGENCY: United States Patent and

Trademark Office, Commerce.

ACTION: Final rule.

SUMMARY: In a rulemaking to implement

the Patent Business Goals, the United

States Patent and Trademark Office

(Office) proposed a change to the time

period within which a deposit of

biological material (if needed) must be

made. The Office held this proposed

change in abeyance pending

consideration of a study by the

Comptroller General of the potential

risks to the United States biotechnology

industry relating to biological deposits

as required by the American Inventors

Protection Act of 1999. The Office is

now, after consideration of this study,

adopting a change to the time period

within which a deposit of biological

material (if needed) must be made and

the depository information added to the

specification.

EFFECTIVE DATE: May 29, 2001. This

change is effective for any application in

which a Notice of Allowability is mailed

on or after May 29, 2001.

FOR FURTHER INFORMATION CONTACT:

Robert W. Bahr, Karin L. Tyson, or

Robert A. Clarke by telephone at (703)

308–6906, or by mail addressed to: Box

Comments—Patents, Commissioner for

Patents, Washington, DC 20231, or by

facsimile to (703) 872–9411, marked to

the attention of Robert W. Bahr.

SUPPLEMENTARY INFORMATION: In October

of 1999, the Office proposed a number

of changes to the rules of practice in

title 37 of the Code of Federal

Regulations to implement the Patent

Business Goals. See Changes to

Implement the Patent Business Goals,

64 FR 53771 (Oct. 4, 1999), 1228 Off.

Gaz. Pat. Office 15 (Nov. 2, 1999)

(Proposed Rule). Among the proposed

changes was a proposal to amend

§ 1.809 to revise the time period within

which a deposit of biological material (if

needed) must be made and the

depository information added to the

specification. See Changes to Implement

the Patent Business Goals, 64 FR 53814,

53842, 1228 Off. Gaz. Pat. Office 52, 78–

79.

Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Rules and Regulations 21091

The American Inventors Protection

Act of 1999 (Title IV of the Intellectual

Property and Communications Omnibus

Reform Act of 1999 (S. 1948) as

introduced in the 106th Congress on

November 17, 1999) was incorporated

and enacted into law on November 29,

1999, by § 1000(a)(9), Division B, of Pub.

L. 106–113, 113 Stat. 1501 (1999).

Section 4805 of the American Inventors

Protection Act of 1999 provides that the

Comptroller General (in consultation

with the Office) shall conduct a study

and submit a report to Congress on the

potential risks to the United States

biotechnology industry relating to

deposits of biological material in

support of biotechnology patents, and

that the Office shall consider the

recommendations of such study in

drafting regulations affecting deposits of

biological material (including any

modification of § 1.801 et seq.).

Therefore, the Office held its proposed

change to § 1.809 in abeyance pending

the completion of the study. See

Changes to Implement the Patent

Business Goals, 65 FR 54603, 54651

(Sept. 8, 2000), 1238 Off. Gaz. Pat.

Office 77, 118–19 (Sept. 19, 2000) (Final

Rule).

The study required by section 4805 of

the American Inventors Protection Act

of 1999 was completed in October of

2000. See Deposits of Biological

Materials in Support of Certain Patent

Applications, GAO–01–49 (Oct. 2000).

This report may be obtained: (1) By mail

addressed to U.S. General Accounting

Office, P.O. Box 37050, Washington, DC

20013; (2) in person by visiting Room

1100, 700 4th Street, NW. (Corner of 4th

Street and G Street, NW.), U.S. General

Accounting Office, Washington, DC, (3)

by telephone at (202) 512–6000,

facsimile at (202) 512–6061, or TDD

(202) 512–2537; or (4) via the General

Accounting Office’s Internet Web site at

http://www.gao.gov. The study did not

contain any recommendations related to

the Office’s proposal to amend § 1.809

to revise the time period within which

a deposit of biological material (if

needed) must be made. Therefore, the

Office is now revising § 1.809 based

upon its October 1999 proposal.

Discussion of Specific Rules

Title 37 of the Code of Federal

Regulations, Part 1, is amended as

follows:

Section 1.136: Section 1.136(c) is

amended to add the period for making

a deposit set under § 1.809(c) to the time

periods that are not extendable under

§ 1.136 if an applicant is notified in a

‘‘Notice of Allowability’’ that an

application is otherwise in condition for

allowance, or in an Office action having

a mail date on or after the mail date of

the ‘‘Notice of Allowability.’’

Section 1.809: Section 1.809(b) is

amended to change ‘‘respond’’ to

‘‘reply’’ (see § 1.111), and to eliminate

the language relating to payment of the

issue fee.

Section 1.809(c) is amended to: (1)

Provide that if an application for patent

is otherwise in condition for allowance

except for a needed deposit and the

Office has received a written assurance

that an acceptable deposit will be made,

applicant will be notified and given a

period of time within which the deposit

must be made in order to avoid

abandonment; (2) provide that this time

period is not extendable under

§ 1.136(a) or (b) if set forth in a ‘‘Notice

of Allowability’’ or in an Office action

having a mail date on or after the mail

date of a ‘‘Notice of Allowability’’ (see

§ 1.136(c)); and (3) eliminate the

language stating that failure to make a

needed deposit will result in

abandonment for failure to prosecute,

because abandonment for failure to

prosecute occurs by operation of law

when an applicant fails to timely

comply with such a requirement (see 35

U.S.C. 133). If an application for patent

is otherwise in condition for allowance

except for a needed deposit, the Office

will notify applicant in the ‘‘Notice of

Allowability’’ that a deposit is required,

and the ‘‘Notice of Allowability’’ will

set a three-month (non-extendable)

period within which the deposit must

be made in order to avoid abandonment

of the application.

Section 1.809(e) is added to remind

applicants that the amendment required

by § 1.809(d) must be filed before or

with the payment of the issue fee. The

rules of practice no longer permit

amendments to be filed after payment of

the issue fee. See § 1.312. Therefore,

applicants need to make any necessary

deposit of biological material well prior

to payment of the issue fee such that the

accession number is received with

sufficient time remaining to amend the

specification as required by § 1.809(d)

on or before the date the issue fee is

paid. If the amendment required by

§ 1.809(d) is not filed before or with the

payment of the issue fee, applicant will

need to submit the amendment with a

petition under § 1.183 to waive the

requirement of § 1.312 that any

amendment after the mailing of a notice

of allowance be filed before or with the

payment of the issue fee so as to permit

entry of the amendment required by

§ 1.809(d).

Finally, applicants are encouraged to

make the deposit when filing the patent

application in order to avoid possible

loss of the U.S. filing date in other

countries. See Manual of Patent

Examining Procedure § 2406.03 (July

1998).

Classification

Administrative Procedure Act: This

final rule only changes the time period

within which a deposit under § 1.801 et

seq. must be filed (if needed). Therefore,

this change concerns only rules of

Office procedure, and prior notice and

an opportunity for public comment for

this change is not required pursuant to

5 U.S.C. 553(b)(A), or any other law.

However, a notice of proposed

rulemaking was published in the

Federal Register and the Official

Gazette, and no comments on the

proposed change were received. See

Changes to Implement the Patent

Business Goals, 64 FR 53771 (Oct. 4,

1999), 1228 Off. Gaz. Pat. Office 15

(Nov. 2, 1999) (Proposed Rule).

Regulatory Flexibility Act: The

Assistant General Counsel for

Legislation and Regulation of the

Department of Commerce certified to

the Chief Counsel for Advocacy of the

Small Business Administration that this

rule will not have a significant

economic impact on a substantial

number of small entities. No comments

were received regarding the economic

impact of this rule. As a result, no

regulatory flexibility analysis was

prepared.

Executive Order 13132: This final rule

does not contain policies with

federalism implications sufficient to

warrant preparation of a Federalism

Assessment under Executive Order

13132 (August 4, 1999).

Executive Order 12866: This final rule

has been determined to be not

significant for purposes of Executive

Order 12866 (September 30, 1993).

Paperwork Reduction Act: This final

rule involves information collection

requirements which are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.). The collection of information

involved in this final rule has been

reviewed and previously approved by

OMB under the following control

number 0651–0022. The United States

Patent and Trademark Office is not

resubmitting an information collection

package to OMB for its review and

approval because the changes in this

final rule do not affect the information

collection requirements associated with

the information collection under OMB

control number 0651–0022.

The title, description and respondent

description of this information

collection is shown below with an

estimate of the annual reporting

21092 Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Rules and Regulations

burdens. Included in the estimate is the

time for reviewing instructions,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information. The

principal impact of the changes in this

final rule is a change in the time period

for filing a deposit under § 1.801 et seq.

(if needed).

OMB Number: 0651–0022.

Title: Deposit of Biological Materials

for Patent Purposes.

Form Numbers: None.

Type of Review: Routine submission.

Affected Public: Individuals or

Households, State or Local

Governments, Farms, Business or Other

For-Profit, Federal Agencies or

Employees, Not-for-Profit Institutions,

Small Businesses or Organizations.

Estimated Number of Respondents:

3,300.

Estimated Time Per Response: 1.0

hour.

Estimated Total Annual Burden

Hours: 3,300 hours.

Needs and Uses: Information on

depositing of biological materials in

depositories is required for (1) Office

determination of compliance with the

patent statute where the invention

sought to be patented relies on

biological material subject to deposit

requirement, which includes notifying

interested members of the public where

to obtain samples of deposits, and (2)

depositories desiring to be recognized as

suitable by the Office.

Comments are invited on: (1) Whether

the collection of information is

necessary for proper performance of the

functions of the agency; (2) the accuracy

of the agency’s estimate of the burden;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

to respondents.

Interested persons are requested to

send comments regarding these

information collections, including

suggestions for reducing this burden, to

Robert J. Spar, Director, Office of Patent

Legal Administration, United States

Patent and Trademark Office,

Washington, DC 20231, or to the Office

of Information and Regulatory Affairs,

OMB, 725 17th Street, NW, Washington,

DC 20503, (Attn: PTO Desk Officer).

Notwithstanding any other provision

of law, no person is required to respond

to nor shall a person be subject to a

penalty for failure to comply with a

collection of information subject to the

requirements of the Paperwork

Reduction Act unless that collection of

information displays a currently valid

OMB control number.

List of Subjects in 37 CFR Part 1

Administrative practice and

procedure, Courts, Freedom of

Information, Inventions and patents,

Reporting and record keeping

requirements, Small Businesses.

For the reasons set forth in the

preamble, 37 CFR Part 1 is amended as

follows:

PART 1—RULES OF PRACTICE IN

PATENT CASES

I. The authority citation for 37 CFR

part 1 continues to read as follows:

Authority: 35 U.S.C. 2(b)(2).

Section 1.136 is amended by revising

paragraph (c) to read as follows:

§ 1.136 Extensions of time.

* * * * *

(c) If an applicant is notified in a

‘‘Notice of Allowability’’ that an

application is otherwise in condition for

allowance, the following time periods

are not extendable if set in the ‘‘Notice

of Allowability’’ or in an Office action

having a mail date on or after the mail

date of the ‘‘Notice of Allowability’’:

(1) The period for submitting an oath

or declaration in compliance with

§ 1.63;

(2) The period for submitting formal

drawings set under § 1.85(c); and

(3) The period for making a deposit

set under § 1.809(c).

Section 1.809 is amended by revising

paragraphs (b) and (c) and adding

paragraph (e) to read as follows:

§ 1.809 Examination procedures.

* * * * *

(b) The applicant for patent or patent

owner shall reply to a rejection under

paragraph (a) of this section by—

(1) In the case of an applicant for

patent, either making an acceptable

original, replacement, or supplemental

deposit, or assuring the Office in writing

that an acceptable deposit will be made;

or, in the case of a patent owner,

requesting a certificate of correction of

the patent which meets the terms of

paragraphs (b) and (c) of § 1.805, or

(2) Arguing why a deposit is not

needed under the circumstances of the

application or patent considered and/or

why a deposit actually made should be

accepted. Other replies to the

examiner’s action shall be considered

nonresponsive. The rejection will be

repeated until either paragraph (b)(1) of

this section is satisfied or the examiner

is convinced that a deposit is not

needed.

(c) If an application for patent is

otherwise in condition for allowance

except for a needed deposit and the

Office has received a written assurance

that an acceptable deposit will be made,

applicant will be notified and given a

period of time within which the deposit

must be made in order to avoid

abandonment. This time period is not

extendable under § 1.136(a) or (b) if set

forth in a ‘‘Notice of Allowability’’ or in

an Office action having a mail date on

or after the mail date of a ‘‘Notice of

Allowability’’ (see § 1.136(c)).

* * * * *

(e) Any amendment required by

paragraphs (d)(1), (d)(2) or (d)(4) of this

section must be filed before or with the

payment of the issue fee (see § 1.312).

Dated: April 18, 2001.

Nicholas P. Godici,

Acting Under Secretary of Commerce for

Intellectual Property and Director of the

United States Patent and Trademark Office.

[FR Doc. 01–10188 Filed 4–26–01; 8:45 am]

BILLING CODE 3510–16–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 62

[Docket # RI040–7167a; FRL–6971–1]

Approval and Promulgation of State

Plans for Designated Facilities and

Pollutants: Rhode Island; Plan for

Controlling Emissions From Existing

Hospital/Medical/Infectious Waste

Incinerators

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: The Environmental Protection

Agency (EPA) approves the Sections

111(d)/129 State Plan submitted by the

Rhode Island Department of

Environmental Management (RIDEM) on

August 23, 2000. This State Plan is for

implementing and enforcing provisions

at least as protective as the Emissions

Guidelines (EGs) applicable to existing

Hospital/Medical/Infectious Waste

Incinerators (HMIWIs) for which

construction commenced on or before

June 20, 1996.

DATES: This direct final rule is effective

on June 26, 2001 without further notice

unless EPA receives significant adverse

comment by May 29, 2001. If adverse

comment is received EPA will publish

a timely withdrawal in the Federal

Register informing the public that this

rule will not take effect.

ADDRESSES: You should address your

written comments to: Mr. Steven Rapp,

Manager, Air Permits Unit, Office of

Ecosystem Protection, U.S. EPA-New

England, Region 1, One Congress Street,