Medical; Nonsubstantive Miscellaneous Changes; Correction, 54496-54497 [2010-22252]

Download as PDF 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. BILLING CODE 4160–01–S mstockstill on DSKH9S0YB1PROD with RULES 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. BILLING CODE P (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 Jkt 220001 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: ‘‘https://vaww1.va.gov/ ORPM/FY_2010_Published_VA_ Regulations.asp’’, which is corrected to read: ‘‘https://www1.va.gov/ORPM/FY_ 2010_Published_VA_Regulations.asp’’. [FR Doc. 2010–22281 Filed 9–7–10; 8:45 am] § 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. 17:27 Sep 07, 2010 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] 2. Section 870.5100 is added to subpart F to read as follows: ■ VerDate Mar<15>2010 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. DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 DEPARTMENT OF VETERANS AFFAIRS RIN 2900–AN54 38 CFR Part 17 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 RIN 2900–AH95 Department of Veterans Affairs. ACTION: Final rule; correction. ACTION: AGENCY: 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, SUMMARY: PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 Medical; Nonsubstantive Miscellaneous Changes; Correction Department of Veterans Affairs. Correcting amendment. AGENCY: 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. SUMMARY: E:\FR\FM\08SER1.SGM 08SER1 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 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.) 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. SUPPLEMENTARY INFORMATION: 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. ENVIRONMENTAL PROTECTION AGENCY ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 40 CFR Part 228 [EPA–R03–OAR–2010–0431; FRL–9197–5] [FRL–9197–6] Approval and Promulgation of Air Quality Implementation Plans; Maryland; Withdrawal of Direct Final Rule Ocean Dumping; Guam Ocean Dredged Material Disposal Site Designation Environmental Protection Agency (EPA). AGENCY: ACTION: Withdrawal of direct final rule. 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 8hour 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. SUMMARY: Effective Date: The direct final rule is withdrawn as of September 8, 2010. DATES: Approved: Robert C. McFetridge, Director, Regulation Policy and Management, Office of the General Counsel, Department of Veterans Affairs. FOR FURTHER INFORMATION CONTACT: For the reason set out in the preamble, VA is correcting 38 CFR part 17 as follows. Environmental protection, Air pollution control, National parks, Wilderness areas. ■ PART 17—MEDICAL 1. The authority citation for part 17 continues to read as follows: ■ Gregory Becoat, (215) 814–2036, or by e-mail at becoat.gregory@epa.gov. List of Subjects in 40 CFR Part 81 Dated: August 18, 2010. Shawn M. Garvin, Regional Administrator, Region III. Authority: 38 U.S.C. 501, 1721, and as stated in specific sections. 2. In part 17, remove the second § 17.31. 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] mstockstill on DSKH9S0YB1PROD with RULES ■ [FR Doc. 2010–22252 Filed 9–7–10; 8:45 am] ■ BILLING CODE 6560–50–P BILLING CODE P VerDate Mar<15>2010 17:27 Sep 07, 2010 Jkt 220001 54497 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 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. SUMMARY: 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\08SER1.SGM 08SER1

Agencies

[Federal Register Volume 75, Number 173 (Wednesday, September 8, 2010)]
[Rules and Regulations]
[Pages 54496-54497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22252]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AH95


Medical; Nonsubstantive Miscellaneous Changes; Correction

AGENCY: Department of Veterans Affairs.

ACTION: Correcting amendment.

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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 Sec.  17.31 and 
inadvertently redesignated Sec.  17.31(b)(5) as the new Sec.  17.31, 
creating two sections for Sec.  17.31. This document will correct that 
error by removing the second, obsolete Sec.  17.31.

DATES: Effective Date: September 8, 2010.

[[Page 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 Sec.  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 Sec.  17.31(b)(5) as Sec.  17.31, 
creating a second Sec.  17.31. The second Sec.  17.31 is obsolete. This 
document corrects the error by removing the second Sec.  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.

0
For the reason set out in the preamble, VA is correcting 38 CFR part 17 
as follows.

PART 17--MEDICAL

0
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.


0
2. In part 17, remove the second Sec.  17.31.

[FR Doc. 2010-22252 Filed 9-7-10; 8:45 am]
BILLING CODE P
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