31372 Federal Register / Vol. 74, No. 125 / Wednesday, July 1, 2009 / Rules and Regulations 

Dated: June 19, 2009. 

P.B. Trapp, 

Captain, U.S. Coast Guard Acting 

Commander, Fifth Coast Guard District. 

[FR Doc. E9–15577 Filed 6–30–09; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

37 CFR Part 1 

[Docket No.: PTO–P–2009–0025] 

RIN 0651–AC34 

July 2009 Revision of Patent 

Cooperation Treaty Procedures 

AGENCY: United States Patent and 

Trademark Office, Commerce. 

ACTION: Final rule. 

SUMMARY: The United States Patent and 

Trademark Office (USPTO) is revising 

the rules of practice in title 37 of the 

Code of Federal Regulations (CFR) to 

conform them to certain amendments 

made to the Regulations under the 

Patent Cooperation Treaty (PCT) that 

take effect on July 1, 2009. These 

amendments result in a change to the 

procedure under the PCT whereby 

applicants may make amendments to 

the claims in an international 

application. 

DATES: Effective Date: The changes to 37 

CFR 1.485 are effective on July 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Richard R. Cole, Senior Legal Examiner, 

Office of PCT Legal Administration 

(OPCTLA) directly by telephone at (571) 

272–3281, or by facsimile at (571) 273– 

0459. 

SUPPLEMENTARY INFORMATION: During the 

September 2008 meeting of the 

Governing Bodies of the World 

Intellectual Property Organization 

(WIPO), the PCT Assembly adopted 

various amendments to the Regulations 

under the PCT that enter into force on 

July 1, 2009. The amended PCT 

Regulations were published in the PCT 

Gazette of December 11, 2008 (38/2008), 

at pages 166–167. The amendments 

include provisions which modify the 

procedures for making amendments to 

the claims in an international 

application. 

The Patent Cooperation Treaty (PCT) 

enables an applicant to file one 

application, ‘‘an international 

application’’ or a ‘‘PCT application,’’ in 

a standardized format in a PCT 

Receiving Office and have that 

application acknowledged as a regular 

national or regional filing in as many 

Contracting States to the PCT as the 

applicant desires. The requirements for 

PCT applications are specified in the 

PCT Treaty Articles and the Regulations 

issued under the PCT Treaty (the PCT 

Regulations). Certain requirements of 

the PCT Treaty and PCT Regulations are 

reiterated in the USPTO’s rules of 

practice in 37 CFR for the convenience 

of patent applicants. Changes to the PCT 

Regulations (PCT Rules 46.5 and 66.8) 

that govern the manner of making 

amendments to the claims in 

international applications will become 

effective on July 1, 2009. Under the 

current PCT Regulations, applicants are 

required to submit replacement pages 

for only those pages which contain 

changes, where under the revised PCT 

Regulations applicants will be required 

to submit a complete set of the claims 

when amending any of the claims. The 

USPTO’s rules of practice in 37 CFR (37 

CFR 1.485) set forth the current practice 

for amending claims and must be 

changed to be consistent with the 

changes to the PCT Regulations. 

The changes to 37 CFR 1.485 are 

effective on July 1, 2009, and apply to 

any amendment filed in an international 

application on or after that date 

regardless of the filing date of the 

international application. 

Discussion of Specific Rules 

Title 37 of the Code of Federal 

Regulations, part 1, is amended as 

follows: 

Section 1.485: Section 1.485 is 

amended to require that amendments to 

the claims in a PCT international 

application must be made in accordance 

with PCT Rule 66.8. 

Rulemaking Considerations 

A. Administrative Procedure Act: The 

change in this final rule merely revises 

the USPTO’s rules of practice to 

conform to the requirements of the PCT 

Regulations that become effective on 

July 1, 2009. 35 U.S.C. 364(a) provides 

that international applications shall be 

processed by the USPTO in accordance 

with the applicable provisions of the 

PCT, the Regulations under the PCT and 

Title 35 of the United States Code. 

Therefore, these rule changes involve 

interpretive rules or rules of agency 

practice and procedure under 5 U.S.C. 

553(b)(A). Accordingly, the changes in 

this final rule may be adopted without 

prior notice and opportunity for public 

comment under 5 U.S.C. 553(b) and (c), 

or thirty-day advance publication under 

5 U.S.C. 553(d). See Cooper Techs. Co. 

v. Dudas, 536 F.3d 1330, 1336–37, 87 

U.S.P.Q.2d 1705, 1710 (Fed. Cir. 2008) 

(stating that 5 U.S.C. 553, and thus 35 

U.S.C. 2(b)(2)(B), does not require notice 

and comment on rulemaking for 

‘‘‘interpretative rules, general statements 

of policy, or rules of agency 

organization, procedure, or practice.’’’ 

(quoting 5 U.S.C. 553(b)(A))). 

B. Regulatory Flexibility Act: As prior 

notice and an opportunity for public 

comment are not required pursuant to 5 

U.S.C. 553 (or any other law), neither a 

regulatory flexibility analysis nor a 

certification under the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) is 

required. See 5 U.S.C. 603. 

C. Executive Order 13132 

(Federalism): This rulemaking does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (Aug. 4, 

1999). 

D. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be significant 

for purposes of Executive Order 12866 

(Sept. 30, 1993). 

E. Executive Order 13175 (Tribal 

Consultation): This rulemaking will not: 

(1) Have substantial direct effects on one 

or more Indian Tribes; (2) impose 

substantial direct compliance costs on 

Indian Tribal governments; or (3) 

preempt Tribal law. Therefore, a Tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

F. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because this 

rulemaking is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Therefore, 

a Statement of Energy Effects is not 

required under Executive Order 13211 

(May 18, 2001). 

G. Executive Order 12988 (Civil 

Justice Reform): This rulemaking meets 

applicable standards to minimize 

litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

3(a) and 3(b)(2) of Executive Order 

12988 (Feb. 5, 1996). 

H. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

I. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not effect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

J. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

Federal Register / Vol. 74, No. 125 / Wednesday, July 1, 2009 / Rules and Regulations 31373 

1996 (5 U.S.C. 801 et seq.), prior to 

issuing any final rule the USPTO will 

submit a report containing the final rule 

and other required information to the 

United States Senate, the United States 

House of Representatives, and the 

Comptroller General of the Government 

Accountability Office. 

K. Unfunded Mandates Reform Act of 

1995: The changes proposed in this 

notice do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, of 100 million dollars (as 

adjusted) or more in any one year, or a 

Federal private sector mandate that will 

result in the expenditure by the private 

sector of 100 million dollars (as 

adjusted) or more in any one year, and 

will not significantly or uniquely affect 

small governments. Therefore, no 

actions are necessary under the 

provisions of the Unfunded Mandates 

Reform Act of 1995. See 2 U.S.C. 1501 

et seq. 

L. National Environmental Policy Act: 

This rulemaking will not have any effect 

on the quality of environment and is 

thus categorically excluded from review 

under the National Environmental 

Policy Act of 1969. See 42 U.S.C. 4321 

et seq. 

M. National Technology Transfer and 

Advancement Act: The requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) are not 

applicable because this rulemaking does 

not contain provisions which involve 

the use of technical standards. 

N. Paperwork Reduction Act: This 

notice 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 notice has been 

reviewed and approved by OMB under 

OMB control number 0651–0021. The 

USPTO is not resubmitting an 

information collection package to OMB 

for its review and approval because the 

changes in this notice do not affect the 

information collection requirements 

associated with the information 

collection under OMB control number 

0651–0021. 

Interested persons are requested to 

send comments regarding these 

information collections, including 

suggestions for reducing this burden, to: 

(1) The Office of Information and 

Regulatory Affairs, Office of 

Management and Budget, New 

Executive Office Building, Room 10202, 

725 17th Street, NW., Washington, DC 

20503, Attention: Desk Officer for the 

Patent and Trademark Office; and (2) 

Robert A. Clarke, Director, Office of 

Patent Legal Administration, 

Commissioner for Patents, P.O. Box 

1450, Alexandria, VA 22313–1450. 

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 recordkeeping 

requirements, Small businesses. 

PART 1—RULES OF PRACTICE IN 

PATENT CASES 

■ 1. The authority citation for 37 CFR 

part 1 continues to read as follows: 

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

■ 2. Section 1.485 is revised to read as 

follows: 

§ 1.485 Amendments by applicant during 

international preliminary examination. 

The applicant may make amendments 

at the time of filing the Demand. The 

applicant may also make amendments 

within the time limit set by the 

International Preliminary Examining 

Authority for reply to any notification 

under § 1.484(b) or to any written 

opinion. Any such amendments must be 

made in accordance with PCT Rule 66.8. 

Dated: June 24, 2009. 

John J. Doll, 

Acting Under Secretary of Commerce for 

Intellectual Property and Acting Director of 

the United States Patent and Trademark 

Office. 

[FR Doc. E9–15303 Filed 6–30–09; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR PART 17 

RIN 2900–AM99 

Civilian Health and Medical Program of 

the Department of Veterans Affairs 

(CHAMPVA): Preauthorization of 

Durable Medical Equipment 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: This document amends the 

Department of Veterans Affairs (VA) 

medical regulations for the Civilian 

Health and Medical Program of the 

Department of Veterans Affairs 

(CHAMPVA) preauthorization section 

by increasing the dollar ceiling for 

purchase or rental of durable medical 

equipment (DME) from $300 to $2,000. 

DATES: Effective Date: The final rule is 

effective July 31, 2009. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Brown, Chief, Policy Management 

Division, VA Health Administration 

Center, P.O. Box 460948, Denver, 

Colorado 80246; (303) 331–7882. (This 

is not a toll-free number). 

SUPPLEMENTARY INFORMATION: In a 

document published in the Federal 

Register on October 28, 2008 (73 FR 

63914), VA proposed to amend its 

medical regulations at 38 CFR Part 17 

concerning CHAMPVA benefits. 

Specifically, it proposed to amend 

§ 17.273(e) regarding durable medical 

equipment (DME) by increasing the 

dollar ceiling for purchase or rental of 

durable medical equipment (DME) from 

the $300 to $2,000. 

CHAMPVA is a VA medical benefits 

program for (1) spouses and children of 

veterans who have a permanent and 

total service-connected disability and 

(2) surviving spouses and children of 

veterans who died as a result of a 

service-connected disability or while 

rated permanently and totally disabled 

from a service-connected disability, or 

who died in the active military, naval, 

or air service in the line of duty and 

there is not otherwise entitlement to 

Department of Defense TRICARE 

benefits. DME is included among the 

health care items that are available to 

CHAMPVA beneficiaries. To ensure that 

DME purchases and rental are medically 

necessary, appropriate and within the 

Department’s budgetary constraints, VA 

requires non-VA providers to obtain 

preauthorization before the purchase or 

rental of DME for a CHAMPVA 

beneficiary when the cost of the DME 

exceeds $300. DME purchases greater 

than $300 are currently reviewed twice, 

i.e., first when a request is submitted for 

preauthorization and again when the 

claim is officially submitted for 

payment. 

The current rate was put in place in 

1973. Since the cost of common DME 

items has steadily increased, this ceiling 

no longer reflects current costs. Raising 

the dollar amount to $2,000 would make 

the administrative processing of DME 

claims easier for CHAMPVA 

beneficiaries and providers as well as 

for VA, since claims under that amount 

will only be reviewed once. 

VA provided a 60-day comment 

period that ended December 29, 2008.