58258 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

SUMMARY: This document makes a 

correction to Airworthiness Directive 

(AD) 2004–19–04. That AD applies to 

Rolls-Royce plc (RR) RB211–22B, 

RB211–524, and RB211–535 series 

turbofan engines. That AD was 

published in the Federal Register on 

September 22, 2004 (69 FR 56683). In 

the amendatory language, under § 39.13 

[Amended], the amendment number for 

the AD was inadvertently omitted. This 

document corrects that omission. In all 

other respects, the original document 

remains the same.

EFFECTIVE DATE: Effective September 30, 

2004.

FOR FURTHER INFORMATION CONTACT:

Christopher Spinney, Aerospace 

Engineer, Engine Certification Office, 

FAA, Engine and Propeller Directorate, 

12 New England Executive Park, 

Burlington, MA 01803–5299; telephone 

(781) 238–7175, fax (781) 238–7199.

SUPPLEMENTARY INFORMATION: A final 

rule AD, FR Doc. 04–21173 that applies 

to RR RB211–22B, RB211–524, and 

RB211–535 series turbofan engines, was 

published in the Federal Register on 

September 22, 2004 (69 FR 56683). The 

following correction is needed:

§ 39.13 [Corrected]

■ On page 56684, in the second column, 

under § 39.13 [Amended], in the fifth 

line, ‘‘2004–19–04 Rolls-Royce plc: 

Docket No.’’ is corrected to read ‘‘2004–

19–04 Rolls-Royce plc: Amendment 39–

13798. Docket No.’’.

Issued in Burlington, MA, on September 

23, 2004. 

Francis A. Favara, 

Acting Manager, Engine and Propeller 

Directorate, Aircraft Certification Service.

[FR Doc. 04–21912 Filed 9–29–04; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 2004P–0354]

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of Sirolimus Test 

System Devices

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

sirolimus test system device into class II 

(special controls). The special control 

that will apply to the device is the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems.’’ The device is 

intended to measure sirolimus levels in 

whole blood as an aid to managing 

therapy for transplant patients receiving 

sirolimus, an immunosuppressive drug. 

The agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability of a guidance document that 

is the special control for this device.

DATES: This rule becomes effective 

November 1, 2004. The classification 

was effective July 28, 2004.

FOR FURTHER INFORMATION CONTACT: Avis 

Danishefsky, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 301–594–

1243, ext. 161.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III until the device is 

classified or reclassified into class I or 

II, or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

act, to a predicate device. The agency 

determines whether new devices are 

substantially equivalent to previously 

marketed devices by means of 

premarket notification procedures in 

section 510(k) of the act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807) 

of FDA’s regulations.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a document in the Federal 

Register announcing such classification 

(section 513(f)(2) of the act).

In accordance with section 513(f)(1) of 

the act, FDA issued a document on June 

15, 2004, classifying the Microgenics 

CEDIA Sirolimus Assay in class III 

because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

June 16, 2004, Microgenics Corp. 

submitted a petition requesting 

classification of the Microgenics CEDIA 

Sirolimus Assay under section 513(f)(2) 

of the act. The manufacturer 

recommended that the device be 

classified into class II.

In accordance with 513(f)(2) of the 

act, FDA reviewed the petition in order 

to classify the device under the criteria 

for classification set forth in 513(a)(1) of 

the act. Devices are to be classified into 

class II if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that the Microgenics 

CEDIA Sirolimus Assay can be 

classified in class II with the 

establishment of special controls. FDA 

believes these special controls, in 

addition to general controls, will 

provide reasonable assurance of safety 

and effectiveness of the device.

The device is assigned the generic 

name sirolimus test system and is 

identified as a device intended to 

quantitatively determine sirolimus 

concentrations in whole blood. 

Measurements are used as an aid in 

management of transplant patients 

receiving therapy with sirolimus.

FDA has identified no direct risks to 

health related to use of sirolimus test 

systems. However, FDA has identified 

improper patient management, which 

involves failure of the test to perform as 

indicated or error in interpretation of 

results, as an indirect risk to health 

related to use of this device. For 

example, a falsely low sirolimus 

measurement could contribute to a 

decision to raise the sirolimus dose 

above that which is necessary for 

therapeutic benefit. This could result in 

increased risk in the form of 

thrombocytopenia, leukopenia, anemia, 

or hyperlipidemia. A falsely high 

sirolimus measurement could contribute 

to a decision to decrease the dose below 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58259

that which is necessary for 

immunosuppression. This could result 

in increased risk of rejection of the 

transplanted organ. Since optimal 

ranges for sirolimus may vary 

depending on the metabolite crossreactivity of the specific assay, as well 

as on clinical factors, use of assay 

results to adjust a treatment regimen 

without consideration of such factors 

could also lead to improper patient 

management. Therefore, in addition to 

the general controls of the act, the 

device is subject to special controls, 

identified as the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Sirolimus Test 

Systems.’’

The class II special controls guidance 

document also provides information on 

how to meet premarket (510(k)) 

submission requirements for the device, 

including recommendations on 

validation of performance 

characteristics and labeling. FDA 

believes that following the class II 

special controls guidance document 

generally addresses the risks to health 

identified in the previous paragraph. 

Therefore, on July 28, 2004, FDA issued 

an order to the petitioner classifying the 

device into class II. FDA is codifying 

this classification by adding 21 CFR 

862.3840.

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for a sirolimus test system 

will need to address the issues covered 

in the special controls guidance. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance or in some other way 

provides equivalent assurance of safety 

and effectiveness.

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirements under section 510(k) of the 

act, if FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. For this type 

of device, FDA has determined that 

premarket notification is necessary to 

provide reasonable assurance of safety 

and effectiveness. FDA review of 

performance characteristics, test 

methodology, and labeling to satisfy 

requirements of § 807.87(e), will provide 

reasonable assurance that acceptable 

levels of performance for both safety 

and effectiveness will be addressed 

before marketing clearance. Thus, 

persons who intend to market this type 

of device must submit to FDA a 

premarket notification containing 

information on the sirolimus test system 

they intend to market, before marketing 

the device.

II. Environmental Impact

The agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required.

III. Analysis of Impacts

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive order.

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of these 

devices into class II will relieve 

manufacturers of the device of the cost 

of complying with the premarket 

approval requirements of section 515 of 

the act (21 U.S.C. 360e), and may permit 

small potential competitors to enter the 

marketplace by lowering their costs, the 

agency certifies that the final rule will 

not have a significant impact on a 

substantial number of small entities.

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $110 

million. FDA does not expect this final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount.

IV. Federalism

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required.

V. Paperwork Reduction Act of 1995

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required.

VI. Reference

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday.

1. Petition from Microgenics Corp., dated 

June 16, 2004.

List of Subjects in 21 CFR Part 862

Medical devices.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 862 is 

amended as follows:

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES

■ 1. The authority citation for 21 CFR 

part 862 continues to read as follows:

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

360j, 371.

■ 2. Section 862.3840 is added to subpart 

D to read as follows:

§ 862.3840 Sirolimus test system.

(a) Identification. A sirolimus test 

system is a device intended to 

quantitatively determine sirolimus 

concentrations in whole blood. 

Measurements are used as an aid in 

management of transplant patients 

receiving therapy with sirolimus.

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems.’’ See § 862.1(d) 

for the availability of this guidance 

document.

58260 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

Dated: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22011 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF COMMERCE

Patent and Trademark Office 

37 CFR Parts 1 and 41 

RIN 0651–AB32 

Rules of Practice Before the Board of 

Patent Appeals and Interferences

AGENCY: United States Patent and 

Trademark Office, Commerce.

ACTION: Final rule; Correcting 

amendments. 

SUMMARY: The United States Patent and 

Trademark Office (Office) is correcting a 

rule that appeared in the Federal 

Register of 12 August 2004 (69 FR 

49960). The document revised the rules 

of practice before the Board of Patent 

Appeals and Interferences and made 

corresponding amendments to rules in 

37 CFR part 1.

DATES: Effective date: September 30, 

2004.

FOR FURTHER INFORMATION CONTACT:

Richard Torczon, 703–308–9797.

SUPPLEMENTARY INFORMATION: In FR Doc. 

04–17699 appearing on page 49960 in 

the Federal Register of 12 August 2004, 

the following correction is made to the 

SUPPLEMENTARY INFORMATION:

On page 49980, first column, third 

full paragraph (answer to comment 69), 

the fourth sentence ‘‘Furthermore, it is 

noted that the appellant can file a 

request for continued prosecution 

pursuant to § 1.114 and then the 

appellant would be able to submit an 

amendment and/or evidence directed to 

only claims unrelated to the new ground 

of rejection and have such considered 

by the examiner.’’ is corrected to read: 

‘‘Furthermore, it is noted that the 

appellant can file a request for 

continued prosecution pursuant to 

§ 1.114 and then the appellant would be 

able to submit an amendment and/or 

evidence also directed to claims 

unrelated to the new ground of rejection 

and have such considered by the 

examiner.’’

List of Subjects 

37 CFR Part 1 

Administrative practice and 

procedure, Biologics, Courts, Freedom 

of information, Inventions and patents, 

Reporting and recordkeeping 

requirements, Small businesses. 

37 CFR Part 41 

Administrative practice and 

procedure, Inventions and patents, 

Lawyers.

■ Therefore, 37 CFR parts 1 and 41 are 

corrected by making the following 

correcting amendments:

PART 1—RULES OF PRACTICE IN 

PATENT CASES

■ 1. The authority citation continues to 

read as follows:

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

otherwise noted.

■ 2. In § 1.248, revise paragraph (c) to 

read as follows:

§ 1.248 Service of papers; manner of 

service; proof of service in cases other than 

interferences.

* * * * *

(c) See § 41.106(e) of this title for 

service of papers in contested cases 

before the Board of Patent Appeals and 

Interferences.

■ 3. In § 1.302, revise paragraph (b) to 

read as follows:

§ 1.302 Notice of appeal.

* * * * *

(b) In interferences, the notice must be 

served as provided in § 41.106(e) of this 

title.

* * * * *

■ 4. In § 1.303, revise paragraph (c) to 

read as follows:

§ 1.303 Civil action under 35 U.S.C. 145, 

146, 306.

* * * * *

(c) A notice of election under 35 

U.S.C. 141 to have all further 

proceedings on review conducted as 

provided in 35 U.S.C. 146 must be filed 

with the Office of the Solicitor and 

served as provided in § 41.106(e) of this 

title.

* * * * *

PART 41—PRACTICE BEFORE THE 

BOARD OF PATENT APPEALS AND 

INTERFERENCES

■ 5. The authority citation continues to 

read as follows:

Authority: 35 U.S.C. 2(b)(2), 3(a)(2)(A), 21, 

23, 32, 41, 134, 135.

■ 6. In § 41.3, revise paragraph (e)(1) to 

read as follows:

§ 41.3 Petitions.

* * * * *

(e) Time for action. (1) Except as 

otherwise provided in this part or as the 

Board may authorize in writing, a party 

may: 

(i) File the petition within 14 days 

from the date of the action from which 

the party is requesting relief, and 

(ii) File any request for 

reconsideration of a petition decision 

within 14 days of the decision on 

petition or such other time as the Board 

may set.

* * * * *

■ 7. In § 41.127, revise paragraph (d) to 

read as follows:

§ 41.127 Judgment.

* * * * *

(d) Rehearing. A party dissatisfied 

with the judgment may file a request for 

rehearing within 30 days of the entry of 

the judgment. The request must 

specifically identify all matters the party 

believes to have been misapprehended 

or overlooked, and the place where the 

matter was previously addressed in a 

motion, opposition, or reply.

■ 8. In § 41.154, revise paragraph (c)(1) to 

read as follows:

§ 41.154 Form of evidence.

* * * * *

(c) * * * 

(1) Each exhibit must have an exhibit 

label with a unique number in a range 

assigned by the Board, the names of the 

parties, and the proceeding number in 

the following format:

JONES EXHIBIT 2001 

Jones v. Smith 

Contested Case 104,999

* * * * *

■ 9. In § 41.155, revise paragraph (b) to 

read as follows:

§ 41.155 Objection; motion to exclude; 

motion in limine.

* * * * *

(b) Other than deposition. For 

evidence other than deposition 

evidence: 

(1) Objection. Any objection must be 

served within five business days of 

service of evidence, other than 

deposition evidence, to which the 

objection is directed. 

(2) Supplemental evidence. The party 

relying on evidence for which an 

objection is timely served may respond 

to the objection by serving supplemental 

evidence within ten business days of 

service of the objection.

* * * * *

Dated: September 24, 2004. 

Jon W. Dudas, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office.

[FR Doc. 04–21966 Filed 9–29–04; 8:45 am] 

BILLING CODE 3510–16–P