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. 

mstockstill on DSKH9S0YB1PROD with RULES

Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 54497 

FOR FURTHER INFORMATION CONTACT: 

Ethan Kalett, Director of Regulatory 

Affairs (107B), Veterans Health 

Administration, Department of Veterans 

Affairs, 810 Vermont Avenue, NW., 

Washington, DC 20420; (202) 461–7633. 

(This is not a toll-free number.) 

SUPPLEMENTARY INFORMATION: On May 

13, 1996, VA published a final rule in 

the Federal Register (61 FR 21964) 

amending its medical regulations in 38 

CFR part 17 by making a number of 

nonsubstantive changes. In the 

document, we removed § 17.31 (a), (b) 

introductory text and (b)(1) through 

(b)(4), (b)(6), (b)(7), and (c), leaving 

(b)(5) and (d). Inadvertenly, we then 

redesignated § 17.31(b)(5) as § 17.31, 

creating a second § 17.31. The second 

§ 17.31 is obsolete. This document 

corrects the error by removing the 

second § 17.31 from 38 CFR part 17. 

List of Subjects in 38 CFR Part 17 

Administrative practice and 

procedure, Alcohol abuse, Alcoholism, 

Claims, Day care, Dental health, Drug 

abuse, Foreign relations, Government 

contracts, Grant programs—health, 

Grant programs—veterans, Health care, 

Health facilities, Health professions, 

Health records, Homeless, Medical and 

dental schools, Medical devices, 

Medical research, Mental health 

programs, Nursing homes, Philippines, 

Reporting and recordkeeping 

requirements, Scholarships and 

fellowships, Travel and transportation 

expenses, Veterans. 

Approved: 

Robert C. McFetridge, 

Director, Regulation Policy and Management, 

Office of the General Counsel, Department 

of Veterans Affairs. 

■ For the reason set out in the preamble, 

VA is correcting 38 CFR part 17 as 

follows. 

PART 17—MEDICAL 

■ 1. The authority citation for part 17 

continues to read as follows: 

Authority: 38 U.S.C. 501, 1721, and as 

stated in specific sections. 

■ 2. In part 17, remove the second 

§ 17.31. 

[FR Doc. 2010–22252 Filed 9–7–10; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 81 

[EPA–R03–OAR–2010–0431; FRL–9197–5] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Maryland; Withdrawal of Direct Final 

Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Withdrawal of direct final rule. 

SUMMARY: Due to an adverse comment, 

EPA is withdrawing the direct final rule 

to extend the attainment date from June 

15, 2010 to June 15, 2011 for the 

Baltimore nonattainment area, which is 

classified as moderate for the 1997 8- 

hour ozone national ambient air quality 

standard (NAAQS). In the direct final 

rule published on July 23, 2010, we 

stated that if we received any adverse 

comments by August 23, 2010, the rule 

would be withdrawn and would not 

take effect. EPA received an adverse 

comment within the comment period. 

EPA will address the comment received 

in a subsequent final action based upon 

the proposed action also published on 

July 23, 2010 (75 FR 43114). EPA will 

not institute a second comment period 

on this action. 

DATES: Effective Date: The direct final 

rule is withdrawn as of September 8, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Gregory Becoat, (215) 814–2036, or by 

e-mail at becoat.gregory@epa.gov. 

List of Subjects in 40 CFR Part 81 

Environmental protection, Air 

pollution control, National parks, 

Wilderness areas. 

Dated: August 18, 2010. 

Shawn M. Garvin, 

Regional Administrator, Region III. 

■ Accordingly, the amendments to 

§ 81.321, published in the direct final 

rule on July 23, 2010 (75 FR 43069), are 

withdrawn as of September 8, 2010. 

[FR Doc. 2010–22344 Filed 9–7–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 228 

[FRL–9197–6] 

Ocean Dumping; Guam Ocean 

Dredged Material Disposal Site 

Designation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The EPA is designating the 

Guam Deep Ocean Disposal Site (G– 

DODS) as a permanent ocean dredged 

material disposal site (ODMDS) located 

offshore of Guam. Dredging is essential 

for maintaining safe navigation at port 

and naval facilities in Apra Harbor and 

other locations around Guam. Beneficial 

re-use of dredged material (e.g., for 

habitat creation, construction material, 

or landfill cover) is preferred over ocean 

disposal. However, not all dredged 

materials are suitable for beneficial reuse, and not all suitable materials can be 

re-used or stockpiled for future use 

given costs, logistical constraints, and 

capacity of existing land disposal or rehandling sites. Therefore, there is a need 

to designate a permanent ODMDS 

offshore of Guam. Disposal operations at 

the site will be limited to a maximum 

of 1 million cubic yards (764,555 cubic 

meters) per calendar year and must be 

conducted in accordance with the Site 

Management and Monitoring Plan and 

any project-specific permit conditions. 

The designated ODMDS will be 

monitored periodically to ensure that 

the site operates as expected. 

DATES: Effective October 8, 2010. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Allan Ota, Dredging and Sediment 

Management Team, U.S. Environmental 

Protection Agency, Region IX (WTR–8), 

75 Hawthorne Street, San Francisco, CA 

94105, telephone (415) 972–3476 or 

FAX: (415) 947–3537 or E-mail: 

ota.allan@epa.gov. 

SUPPLEMENTARY INFORMATION: The 

supporting document for this site 

designation is the Final Environmental 

Impact Statement for the Designation of 

an Ocean Dredged Material Disposal 

Site Offshore of Guam. This document 

is available for public inspection at the 

following locations: 

1. Guam EPA’s Main Office, 17–3304 

Mariner Avenue, Tiyan, Guam 96913. 

2. Nieves M. Flores Memorial Public 

Library, 254 Martyr Street, Hagatna, 

Guam 96910. 

3. Barrigada Public Library, 177 San 

Roque Drive, Barrigada, Guam 96913. 

mstockstill on DSKH9S0YB1PROD with RULES