Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 54493 

betamethasone acetate equivalent to 

0.89 mg betamethasone alcohol. 

(b) Sponsor. See No. 000061 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Instill one or two drops of 

solution in the conjunctival sac three or 

four times a day. 

(2) Indications for use. For treatment 

of external bacterial infections of the eye 

(conjunctiva and cornea). 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: September 1, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22276 Filed 9–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2000–P–0924] (formerly 

Docket No. FDA–2000–P–1533) 

Cardiovascular Devices; 

Reclassification of Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

the device type, standard percutaneous 

transluminal coronary angioplasty 

(PTCA) catheters, from class III 

(premarket approval) into class II 

(special controls). Cutting/scoring PTCA 

catheters remain in class III and 

continue to require premarket approval 

applications (PMAs). FDA is 

reclassifying these devices in 

accordance with the Federal Food, Drug, 

and Cosmetic Act (the act). Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of a 

guidance document entitled ‘‘Guidance 

for Industry and FDA Staff: Class II 

Special Controls Guidance Document 

for Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters’’ that will serve as the special 

control for the reclassified device type. 

DATES: This final rule is effective 

October 8, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn O’Callaghan, Center for Devices 

and Radiological Health (HFZ–450), 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–6349. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 (the 

SMDA) (Public Law 101–629), and the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Public Law 105–115), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the act, devices 

that were in commercial distribution 

before May 28, 1976 (the date of 

enactment of the 1976 amendments), 

generally referred to as preamendments 

devices, are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f)) of the act (21 

U.S.C. 360c(f)) into class III without any 

FDA rulemaking process. Those devices 

remain in class III and require 

premarket approval, unless and until: 

(1) The device is reclassified into class 

I or II; (2) FDA issues an order 

classifying the device into class I or II 

in accordance with section 513(f)(2) of 

the act (21 U.S.C. 360c(f)(2)); or (3) FDA 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the act (21 U.S.C. 360c(i)), to 

a predicate device that does not require 

premarket approval. The agency 

determines whether new devices are 

substantially equivalent to previously 

offered devices by means of premarket 

notification (510(k)) procedures in 

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

360(k)) and part 807 of the regulations 

(21 CFR part 807). 

A preamendments device that has 

been classified into class III may be 

marketed, by means of premarket 

notification procedures, without 

submission of a PMA until FDA issues 

a final regulation under section 515(b) 

of the act (21 U.S.C. 360e(b)) requiring 

premarket approval. 

Reclassification of postamendments 

devices is governed by section 513(f)(3) 

of the act (21 U.S.C.360c(f)(3)). This 

section states that FDA may initiate the 

reclassification of a device classified 

into class III under section 513(f)(1) of 

the act, or that a manufacturer or 

importer of a device may petition the 

Secretary of Health and Human Services 

(the Secretary) for the issuance of an 

order classifying the device into class I 

or class II. FDA’s regulations in 21 CFR 

860.134 set forth the procedures for the 

filing and review of a petition for 

reclassification of such class III devices. 

In order to change the classification of 

the device, it is necessary that the 

proposed new class have sufficient 

regulatory controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. 

Under section 513(f)(3)(B)(i) of the 

act, the Secretary may, for good cause 

shown, refer a petition to a device 

panel. If a petition is referred to a panel, 

the panel shall make a recommendation 

to the Secretary respecting approval or 

denial of the petition. Any such 

recommendation shall contain: (1) A 

summary of the reasons for the 

recommendation, (2) a summary of the 

data upon which the recommendation is 

based, and (3) an identification of the 

risks to health (if any) presented by the 

device with respect to which the 

petition was filed. 

II. Regulatory History of the Device 

The PTCA catheter is a 

postamendments device classified into 

class III under section 513(f)(1) of the 

act. Therefore, the device cannot be 

placed in commercial distribution 

unless it is subject to an approved 

premarket approval application (PMA) 

under section 515 of the act (21 U.S.C. 

360e) or is reclassified. 

On September 21, 2000, FDA filed a 

petition submitted under section 

513(f)(3) of the act from COOK 

requesting reclassification of PTCA 

catheters from class III into class II. This 

reclassification petition did not include 

cutting or scoring PTCA catheters. In 

order to reclassify the PTCA catheter 

into class II, it is necessary that the 

proposed class have sufficient 

regulatory controls to provide 

reasonable assurance of safety and 

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54494 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 

effectiveness of the device for its 

intended use. 

The COOK petition requested 

reclassification of PTCA catheters from 

class III to class II when indicated for 

balloon dilatation of a hemodynamically 

significant coronary artery or bypass 

graft stenosis in patients evidencing 

coronary ischemia for the purpose of 

improving myocardial perfusion. 

Consistent with the act and the 

regulation, FDA referred the petition to 

the Panel for its recommendation on the 

requested changes in classification. FDA 

also asked the Circulatory System 

Devices Panel for its recommendation 

on the reclassification of PTCA catheters 

when used for treatment of acute 

myocardial infarction (MI), treatment of 

in-stent restenosis (ISR) and/or postdeployment stent expansion. 

III. Device Description 

FDA identifies this generic type of 

device, the subject of this 

reclassification, as follows: Standard 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheter. A PTCA 

catheter is a device that operates on the 

principle of hydraulic pressurization 

applied through an inflatable balloon 

attached to the distal end. A PTCA 

balloon catheter has a single or double 

lumen shaft. The catheter features a 

balloon of appropriate compliance for 

the clinical application, constructed 

from a polymer. The balloon is designed 

to uniformly expand to a specified 

diameter and length at a specific 

pressure as labeled, with well 

characterized rates of inflation and 

deflation and a defined burst pressure. 

The device generally features a type of 

radiographic marker to facilitate 

fluoroscopic visualization of the balloon 

during use. A PTCA catheter is intended 

for balloon dilatation of a 

hemodynamically significant coronary 

artery or bypass graft stenosis in 

patients evidencing coronary ischemia 

for the purpose of improving myocardial 

perfusion. A PTCA catheter may also be 

intended for the treatment of acute 

myocardial infarction; treatment of instent restenosis (ISR) and/or postdeployment stent expansion. 

FDA is also issuing the following 

identification for the devices that will 

remain in class III: A cutting/scoring 

PTCA catheter is a balloon-tipped 

catheter with cutting/scoring elements 

attached, which is used in those 

circumstances where a high pressure 

balloon resistant lesion is encountered. 

A cutting/scoring PTCA catheter is 

intended for the treatment of 

hemodynamically significant coronary 

artery stenosis for the purpose of 

improving myocardial perfusion. A 

cutting/scoring PTCA catheter may also 

be indicated for use in complex type C 

lesions or for the treatment of in-stent 

restenosis. 

IV. Recommendation of the Panel 

At a public meeting on December 4, 

2000, the Panel recommended (seven to 

one) that PTCA catheters be reclassified 

from class III to class II, when indicated 

for balloon dilatation of a 

hemodynamically significant coronary 

artery or bypass graft stenosis in 

patients evidencing coronary ischemia 

for the purpose of improving myocardial 

perfusion; or for treatment of acute 

myocardial infarction. The Panel did 

not recommend reclassification for 

PTCA catheters indicated for the 

treatment of in-stent restenosis and/or 

post-deployment stent expansion. The 

Panel recommended a guidance 

document, labeling, and postmarket 

surveillance as special controls. The 

Panel stated that the special controls 

will diminish some of the risks to health 

associated with certain PTCA catheters. 

The guidance document and labeling 

controls are intended to ensure the 

appropriate performance and use of the 

device by physicians. The Panel 

recommended postmarket surveillance 

as a special control to confirm that the 

other special controls being applied to 

these devices would be sufficient to 

ensure that there would not be an 

increase in adverse consequences to 

patients. In summary, the Panel 

believed that class II with special 

controls would provide reasonable 

assurance of the safety and effectiveness 

of the device. 

The Panel recommended that PTCA 

catheters for the treatment of in-stent 

restenosis and/or post-deployment stent 

expansion not be included because of a 

lack of sufficient information about this 

use. Since the Panel meeting, however, 

additional data regarding this use have 

become available and have been 

reviewed by the agency. 

FDA considered the Panel’s 

recommendations and tentatively agreed 

that PTCA catheters, other than cutting/ 

scoring PTCA catheters, should be 

reclassified from class III into class II 

because special controls, in addition to 

general controls, would provide 

reasonable assurance of the safety and 

effectiveness of the device, and there is 

sufficient information to establish 

special controls to provide such 

assurance. 

Although the Panel included the 

possibility of requiring postmarket 

surveillance in their recommendation, 

FDA did not agree that specific 

postmarket surveillance such as device 

tracking or postapproval studies are 

needed for PTCA catheters. FDA 

believes that periodic assessment of 

adverse event reports through medical 

device reporting submitted to the 

agency is sufficient to address adverse 

effects caused by these devices and is 

the least burdensome way to gather this 

data for PTCA catheters. This practice is 

consistent with the manner in which 

these devices have been regulated as 

class III devices since the Panel meeting. 

Further, after a review of adverse 

event reports submitted to FDA’s 

Manufacturer and User Facility Device 

Experience (MAUDE) Database, the 

agency believes that the types of risks 

associated with the use of PTCA 

catheters for the treatment of in-stent 

restenosis and/or post-deployment stent 

expansion are similar enough to the 

risks associated with treatment of de 

novo lesions, such that the special 

controls discussed at the Panel meeting, 

with the addition of recommendations 

for specific nonclinical performance 

testing and the recommendation that instent restenosis patients be included in 

the clinical evaluation, when necessary, 

are adequate to control the risks to 

health for these devices. 

Accordingly, in the Federal Register 

of May 30, 2008 (73 FR 31123), FDA 

issued the Panel’s recommendation for 

public comment. FDA did not receive 

any comments regarding the Panel’s 

recommendation. Elsewhere in this 

issue of the Federal Register, comments 

received regarding the draft guidance 

document are addressed in the notice of 

availability announcing the special 

controls guidance document. 

V. FDA’s Conclusion 

After reviewing the data in the 

petition and presented at the Panel 

meeting, and after considering the 

Panel’s recommendation and the 

comments on the notice of panel 

recommendation, FDA has determined 

that the device type, standard 

percutaneous transluminal coronary 

angioplasty (PTCA) catheters, can be 

reclassified from class III into class II. 

On August 19, 2010, FDA issued an 

order to the petitioner reclassifying the 

devices into class II (special controls). 

The order also identified the special 

control applicable to these devices as a 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document 

for Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters.’’ This class II special controls 

guidance document is now the special 

control for this device type. 

An alternative approach to the special 

controls guidance document may be 

used if such approach satisfies the 

applicable statute and regulations. 

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Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 54495 

Following the effective date of this final 

classification rule, any firm submitting 

a 510(k) premarket notification for this 

device type will need to address the 

issues covered in the special control 

guidance. However, the firm need only 

show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness. 

Accordingly, as required by 21 CFR 

860.134(b)(6) and (b)(7) of the 

regulations, FDA is announcing the 

reclassification of the standard 

percutaneous transluminal coronary 

angioplasty (PTCA) catheters, from class 

III into class II. In addition, FDA is 

issuing this final rule to codify the 

reclassification of the device by adding 

new § 870.5100. 

VI. 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. 

VII. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and 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. Reclassification of this device 

type, from class III to class II, will 

relieve manufacturers of the device of 

the cost of complying with the 

premarket approval requirements in 

section 515 of the act (21 U.S.C. 360e). 

Because reclassification will reduce 

regulatory costs with respect to this 

device, the agency certifies that the rule 

will not have a significant economic 

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 $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

Based on an assessment of identified 

risks associated with the use of PTCA 

catheters, FDA finds the requirements 

associated with a premarket approval as 

a class III device do not provide an 

added public health benefit over those 

that would result from the requirements 

under a class II (with special controls). 

At the same time, PTCA catheter 

manufactures, as makers of class III 

devices, bear all the costs associated 

with a premarket approval, including 

the cost of submitting the premarket 

approval application (PMA) and 

payment of user fees. One previously 

published estimate (in 73 FR 7497) 

suggests that the costs to prepare a PMA 

could potentially reach $1,000,000, in 

addition to user fees of $217,787 in FY 

(fiscal year) 2010. 

In contrast, if reclassification becomes 

final, manufacturers of a PTCA catheter 

would pay a user fee of $4,007 for a 

510(k) submission in FY 2010. While we 

do not have data to estimate the cost of 

preparing a 510(k) submission, several 

different factors indicate that it would 

be less than the cost of a PMA. For 

example, a firm does not have to submit 

manufacturing information in its 510(k), 

which is required for a PMA 

application, thereby reducing the 

burden and documentation needed. 

Given the ability to evaluate nonclinical 

testing in a direct comparison to a 

predicate device in a 510(k), FDA 

anticipates that most new PTCA 

catheters will not require clinical data to 

support 510(k) clearance, whereas all 

PMAs have to include some form of 

clinical data to support PMA approval. 

This difference will result in a 

significant reduction in cost for the 

device manufacturer. A PMA also 

requires the sponsor to prepare a draft 

summary of safety and effectiveness 

document, which is not required for a 

510(k). 

Based on the most recent 5 years, FDA 

estimates the following annual number 

of submissions received for PTCA 

catheters: 15 ‘‘30-day Notice’’ PMA 

supplements, 1 ‘‘Normal 180-day Track’’ 

PMA supplement, and 2 ‘‘Real-Time 

Process’’ PMA supplements. (Note: FDA 

has not received any ‘‘Panel-Track’’ 

supplements or original PMA 

submissions for this device in the past 

5 years.) A ‘‘30-day Notice’’ is submitted 

for changes to a manufacturing process 

or method and assessed a user fee of 

$3,485 in FY 2010. When 

reclassification is final, these types of 

changes will not require clearance prior 

to the firm making the change in the 

majority of cases. Modifications to the 

method of manufacture of a device 

could require submission of a 510(k) if 

the changes could significantly affect 

the safety or effectiveness of the device, 

such as those that would currently 

require a ‘‘Real-Time Process’’ or ‘‘PanelTrack’’ PMA supplement. Based on 

FDA’s experience, submission of a 

510(k) for a modification to the method 

of manufacturing would be rare. 

In summary, this device 

reclassification would reduce the 

existing burden on manufacturers of 

PTCA catheters. The application of class 

II (with special controls) requirements 

would be consistent with the principle 

of applying the least degree of 

regulatory control necessary to provide 

reasonable assurance of safety and 

effectiveness. 

VIII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe *** a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. (See 

section 512 of the act (21 U.S.C. 360k); 

Medtronic v. Lohr, 518 U.S. 470 (1996); 

Riegel v. Medtronic, 128 S. Ct. 999 

(2008)). The special controls established 

by this final rule create ‘‘requirements’’ 

for specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors have some flexibility in how 

they meet those requirements. Papike v. 

Tambrands, Inc., 107 F.3d 737, 740–42 

(9th Cir. 1997). 

IX. Paperwork Reduction Act of 1995 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

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54496 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 

(OMB) under the Paperwork Reduction 

Act of 1995 is not required. Elsewhere 

in this issue of the Federal Register, 

FDA is issuing a notice announcing the 

guidance for the final rule. This 

guidance, ‘‘Guidance for Industry and 

FDA Staff: Class II Special Controls 

Guidance Document for Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters,’’ 

references previously approved 

collections of information found in FDA 

regulations. 

List of Subjects in 21 CFR Part 870 

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 870 is 

amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

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

360j, 371. 

■ 2. Section 870.5100 is added to 

subpart F to read as follows: 

§ 870.5100 Percutaneous Transluminal 

Coronary Angioplasty (PTCA) Catheter. 

(a) Standard PTCA Catheter—(1) 

Identification. A PTCA catheter is a 

device that operates on the principle of 

hydraulic pressurization applied 

through an inflatable balloon attached to 

the distal end. A PTCA balloon catheter 

has a single or double lumen shaft. The 

catheter features a balloon of 

appropriate compliance for the clinical 

application, constructed from a 

polymer. The balloon is designed to 

uniformly expand to a specified 

diameter and length at a specific 

pressure as labeled, with well 

characterized rates of inflation and 

deflation and a defined burst pressure. 

The device generally features a type of 

radiographic marker to facilitate 

fluoroscopic visualization of the balloon 

during use. A PTCA catheter is intended 

for balloon dilatation of a 

hemodynamically significant coronary 

artery or bypass graft stenosis in 

patients evidencing coronary ischemia 

for the purpose of improving myocardial 

perfusion. A PTCA catheter may also be 

intended for the treatment of acute 

myocardial infarction; treatment of instent restenosis (ISR) and/or postdeployment stent expansion. 

(2) Classification. Class II (special 

controls). The special control for this 

device is ‘‘Class II Special Controls 

Guidance Document for Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters.’’ See 

§ 870.1(e) for the availability of this 

guidance document. 

(b) Cutting/scoring PTCA Catheter— 

(1) Identification. A cutting/scoring 

PTCA catheter is a balloon-tipped 

catheter with cutting/scoring elements 

attached, which is used in those 

circumstances where a high pressure 

balloon resistant lesion is encountered. 

A cutting/scoring PTCA catheter is 

intended for the treatment of 

hemodynamically significant coronary 

artery stenosis for the purpose of 

improving myocardial perfusion. A 

cutting/scoring PTCA catheter may also 

be indicated for use in complex type C 

lesions or for the treatment of in-stent 

restenosis. 

(2) Classification. Class III (premarket 

approval). As of May 28, 1976, an 

approval under section 515 of the act is 

required before this device may be 

commercially distributed. See § 870.3. 

Dated: August 31, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–22304 Filed 9–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 3 

RIN 2900–AN54 

Diseases Associated With Exposure to 

Certain Herbicide Agents (Hairy Cell 

Leukemia and Other Chronic B-Cell 

Leukemias, Parkinson’s Disease and 

Ischemic Heart Disease); Correction 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule; correction. 

SUMMARY: The Department of Veterans 

Affairs (VA) published in the Federal 

Register on August 31, 2010, a 

document amending the adjudication 

regulations concerning the presumptive 

service connection for certain diseases 

based upon the most recent National 

Academy of Sciences Institute of 

Medicine committee report, Veterans 

and Agent Orange: Update 2008. In the 

preamble of that document, VA 

inadvertently included an incorrect Web 

site address. This document corrects the 

Web site address. 

DATES: Effective Date: This correction is 

effective September 8, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Janet Coleman, Office of Regulation 

Policy and Management, Department of 

Veterans Affairs, 810 Vermont Avenue, 

NW., Washington, DC 20420, (202) 461– 

4902 (This is not a toll-free number.). 

SUPPLEMENTARY INFORMATION: On August 

31, 2010, VA published in the Federal 

Register (75 FR 53202), an amendment 

to 38 CFR 3.309 to add hairy cell 

leukemia and other chronic B-cell 

leukemias, Parkinson’s disease and 

ischemic heart disease to the list of 

diseases subject to presumptive service 

connection based on herbicide 

exposure. On page 53215 of that 

document, in the third column, second 

paragraph, we inadvertently provided a 

Web site of: ‘‘http://vaww1.va.gov/

ORPM/FY_2010_Published_VA_

Regulations.asp’’, which is corrected to 

read: ‘‘http://www1.va.gov/ORPM/FY_

2010_Published_VA_Regulations.asp’’. 

List of Subjects in 38 CFR Part 3 

Administrative practice and 

procedure, Claims, Disability benefits, 

Health care, Pensions, Radioactive 

materials, Veterans, Vietnam. 

Approved: September 2, 2010. 

Robert C. McFetridge, 

Director, Regulation Policy and Management, 

Office of the General Counsel, Department 

of Veterans Affairs. 

[FR Doc. 2010–22281 Filed 9–7–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AH95 

Medical; Nonsubstantive 

Miscellaneous Changes; Correction 

AGENCY: Department of Veterans Affairs. 

ACTION: Correcting amendment. 

SUMMARY: The Department of Veterans 

Affairs (VA) published a final rule in the 

Federal Register on May 13, 1996 (61 

FR 21964), amending its medical 

regulations in 38 CFR part 17 by making 

a number of nonsubstantive changes. 

Specifically, section numbers were 

redesignated, redundant and obsolete 

material was removed, certain position 

and organizational titles were changed, 

and material previously deleted was 

restored. The document contained an 

error in an amendatory instruction. We 

removed portions of § 17.31 and 

inadvertently redesignated § 17.31(b)(5) 

as the new § 17.31, creating two sections 

for § 17.31. This document will correct 

that error by removing the second, 

obsolete § 17.31. 

DATES: Effective Date: September 8, 

2010. 

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