Medical Devices; Technical Amendment, 18233-18234 [2013-06826]

Download as PDF Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Rules and Regulations effective September 15, 2012, is amended as follows: FOR FURTHER INFORMATION CONTACT: Paragraph 6010 VOR Federal Airways. (a) Domestic VOR Federal airways. * * * * * V–233 From Spinner, IL; INT Spinner 061° and Roberts, IL, 233° radials; Roberts; Knox, IN; Goshen, IN; Litchfield, MI; Lansing, MI; Mount Pleasant, MI; INT Mount Pleasant 351° and Gaylord, MI, 207° radials; Gaylord; to Pellston, MI. * * * * * Issued in Washington, DC, March 13, 2013. Gary A. Norek, Manager, Airspace Policy and ATC Procedures Group. [FR Doc. 2013–06365 Filed 3–25–13; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 [Docket No. FDA–2013–N–0011] Medical Devices; Technical Amendment AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: SUMMARY: The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency’s regulations. DATES: This rule is effective March 26, 2013. Abigail Corbin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 4430, Silver Spring, MD 20993–0002, 301–796–9142. SUPPLEMENTARY INFORMATION: FDA is amending certain regulations in 21 CFR parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892. This action corrects minor spelling errors and outdated Web site addresses affecting certain regulations regarding medical devices. Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). These amendments are merely correcting nonsubstantive errors. FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary. FDA has determined under 21 CFR 25.30(i) that this final rule 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. In addition, FDA has determined that this final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. List of Subjects 21 CFR Part 814 Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements. 21 CFR Part 822 Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 862 Medical devices. 18233 21 CFR Part 864 Blood, Medical devices, Packaging and containers. 21 CFR Part 866 Biologics, Laboratories, Medical devices. 21 CFR Part 868, 870, 872, 874, 876, 878, and 880 Medical devices. 21 CFR Part 882 Medical devices, Neurological devices. 21 CFR Part 884 Medical devices. 21 CFR Part 886 Medical devices, Ophthalmic goods and services. 21 CFR Part 888 Medical devices. 21 CFR Part 890 Medical devices, Physical medicine devices. 21 CFR Part 892 Medical devices, Radiation protection, X-rays. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR Chapter I is amended as follows: §§ 814.20, 822.7, 822.15, 862.1, 864.1, 866.1, 868.1, 870.1, 872.1, 874.1, 876.1, 878.1, 880.1, 882.1, 884.1, 886.1, 888.1, 890.1, and 892.1 [Amended] 1. In the table below, for each section indicated in the left column, remove the Web address indicated in the middle column from wherever it appears in the section, and add the Web address indicated in the right column: Remove Add 814.20 ................................................................ https://www.fda.gov/cdrh/devadvice/pma/ .......... 822.7 .................................................................. https://www.fda.gov/cdrh/ombudsman/dispute.html. 822.15 ................................................................ tkelley on DSK3SPTVN1PROD with RULES Section www.fda.gov/cdrh/ombudsman/ ....................... 862.1, 864.1, 866.1, 868.1, 870.1, 872.1, 874.1, 876.1, 878.1, 880.1, 882.1, 884.1, 886.1, 888.1, 890.1, and 892.1. https://www.fda.gov/cdrh/guidance.html ............. https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarketYourDevice/ PremarketSubmissions/ PremarketApprovalPMA/default.htm. https://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDRH/ CDRHOmbudsman/default.htm. https://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDRH/ CDRHOmbudsman/default.htm. https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. VerDate Mar<15>2010 16:42 Mar 25, 2013 Jkt 229001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\26MRR1.SGM 26MRR1 18234 Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Rules and Regulations PART 870—CARDIOVASCULAR DEVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 1005—IMPORTATION OF ELECTRONIC PRODUCTS 2. The authority citation for 21 CFR part 870 continues to read as follows: Food and Drug Administration ■ ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 3. Amend § 870.3600 by revising the second sentence in paragraph (a) to read as follows: 21 CFR Part 1005 Authority: 21 U.S.C. 360ii, 360mm. [Docket No. FDA–2007–N–0091; (formerly 2007N–0104)] ■ § 870.3600 generator. External pacemaker pulse (a) Identification. * * * This device, which is used outside the body, is used as a temporary substitute for the heart’s intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. * * * * * * * * ■ 4. Amend § 870.5300 by revising the section heading to read as follows: § 870.5300 paddles). DC-defibrillator (including * * * * * PART 882—NEUROLOGICAL DEVICES 5. The authority citation for 21 CFR part 882 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 6. Amend § 882.5870 by revising the second sentence in paragraph (a) to read as follows: ■ § 882.5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. * * * The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient’s skin to the implanted receiver. * * * * * PART 886—OPHTHALMIC DEVICES 7. The authority citation for 21 CFR part 886 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 8. Amend § 886.1120 by revising the section heading to read as follows: ■ tkelley on DSK3SPTVN1PROD with RULES § 886.1120 Ophthalmic camera. * * * * * Dated: March 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06826 Filed 3–25–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:42 Mar 25, 2013 Jkt 229001 1. The authority citation for 21 CFR part 1005 continues to read as follows: § 1005.25 [Amended] 2. Section 1005.25(b) is amended by removing ‘‘Center for Devices and Radiological Health (HFZ–240), 9200 Corporate Blvd., Rockville, MD 20850’’ and by adding in its place ‘‘Center for Devices and Radiological Health, 10903 New Hampshire Ave., Document Mail Center—WO66–G609, Silver Spring, MD 20993–0002’’. ■ Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of April 9, 2007 (72 FR 17397 at 17401) to reflect changes to the Center for Devices and Radiological Health’s address. This action is editorial in nature and is intended to improve the accuracy of the Agency’s regulations. DATES: This rule is effective March 26, 2013 FOR FURTHER INFORMATION CONTACT: Prince P. Kangoma, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. G628B, 301–796– 6627, FAX: 301–595–7850, email: Prince.Kangoma@fda.hhs.gov. SUMMARY: FDA is making technical amendments in the Agency’s regulations under 21 CFR 1005.25(b) as a result of an office relocation. The former address was 9200 Corporate Blvd., Rockville, MD 20850. The new address is 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Designation of agent by manufacturers of electronic products offering such products for importation into the United States must be addressed to the Center for Devices and Radiological Health, Document Mail Center—WO66–G609. Publication of this document constitutes final action of these changes under the Administrative Procedures Act (5 U.S.C. 553). Notice and public procedures are unnecessary because FDA is merely updating nonsubstantive content. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 1005 Administrative practice and procedure; Electronic product; Imports; Radiation protection; Surety bonds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 1005 is amended as follows: PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Dated: March 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06864 Filed 3–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 970 Demolition or Disposition of Public Housing Projects CFR Correction In Title 24 of the Code of Federal Regulations, Parts 700 to 1699, revised as of April 1, 2012, on page 490, in § 970.27, redesignate paragraph (c) introductory text as paragraph (b). ■ [FR Doc. 2013–07091 Filed 3–25–13; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 Section 482: Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement CFR Correction In Title 26 of the Code of Federal Regulations, Part 1 (§§ 1.441 to 1.500), revised as of April 1, 2012, on page 604, in § 1.482–1, in paragraph (c)(1), before the last sentence, reinstate the following sentence: ■ § 1.482–1 Allocation of income and deductions among taxpayers. * E:\FR\FM\26MRR1.SGM * * 26MRR1 * *

Agencies

[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Rules and Regulations]
[Pages 18233-18234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06826]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 
880, 882, 884, 886, 888, 890, and 892

[Docket No. FDA-2013-N-0011]


Medical Devices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending certain 
medical device regulations to correct minor errors in the Code of 
Federal Regulations (CFR). This action is editorial in nature and is 
intended to provide accuracy and clarity to the Agency's regulations.

DATES: This rule is effective March 26, 2013.

FOR FURTHER INFORMATION CONTACT: Abigail Corbin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, rm. 4430, Silver Spring, MD 20993-0002, 301-796-9142.

SUPPLEMENTARY INFORMATION: FDA is amending certain regulations in 21 
CFR parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 
882, 884, 886, 888, 890, and 892. This action corrects minor spelling 
errors and outdated Web site addresses affecting certain regulations 
regarding medical devices.
    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). These 
amendments are merely correcting nonsubstantive errors. FDA therefore, 
for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that 
notice and public comment are unnecessary.
    FDA has determined under 21 CFR 25.30(i) that this final rule 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. In 
addition, FDA has determined that this final rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

List of Subjects

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 862

    Medical devices.

21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 868, 870, 872, 874, 876, 878, and 880

    Medical devices.

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 884

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 888

    Medical devices.

21 CFR Part 890

    Medical devices, Physical medicine devices.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
Chapter I is amended as follows:


Sec. Sec.  814.20, 822.7, 822.15, 862.1, 864.1, 866.1, 868.1, 870.1, 
872.1, 874.1, 876.1, 878.1, 880.1, 882.1, 884.1, 886.1, 888.1, 890.1, 
and 892.1  [Amended]

    1. In the table below, for each section indicated in the left 
column, remove the Web address indicated in the middle column from 
wherever it appears in the section, and add the Web address indicated 
in the right column:

------------------------------------------------------------------------
             Section                    Remove                Add
------------------------------------------------------------------------
814.20..........................  https://www.fda.gov/ https://www.fda.gov/
                                   cdrh/devadvice/     MedicalDevices/
                                   pma/.               DeviceRegulationa
                                                       ndGuidance/
                                                       HowtoMarketYourDe
                                                       vice/
                                                       PremarketSubmissi
                                                       ons/
                                                       PremarketApproval
                                                       PMA/default.htm.
822.7...........................  https://www.fda.gov/ https://www.fda.gov/
                                   cdrh/ombudsman/     AboutFDA/
                                   dispute.html.       CentersOffices/
                                                       OfficeofMedicalPr
                                                       oductsandTobacco/
                                                       CDRH/
                                                       CDRHOmbudsman/
                                                       default.htm.
822.15..........................  www.fda.gov/cdrh/   https://www.fda.gov/
                                   ombudsman/.         AboutFDA/
                                                       CentersOffices/
                                                       OfficeofMedicalPr
                                                       oductsandTobacco/
                                                       CDRH/
                                                       CDRHOmbudsman/
                                                       default.htm.
862.1, 864.1, 866.1, 868.1,       https://www.fda.gov/ https://www.fda.gov/
 870.1, 872.1, 874.1, 876.1,       cdrh/               MedicalDevices/
 878.1, 880.1, 882.1, 884.1,       guidance.html.      DeviceRegulationa
 886.1, 888.1, 890.1, and 892.1.                       ndGuidance/
                                                       GuidanceDocuments/
                                                       default.htm.
------------------------------------------------------------------------


[[Page 18234]]

PART 870--CARDIOVASCULAR DEVICES

0
2. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
3. Amend Sec.  870.3600 by revising the second sentence in paragraph 
(a) to read as follows:


Sec.  870.3600  External pacemaker pulse generator.

    (a) Identification. * * * This device, which is used outside the 
body, is used as a temporary substitute for the heart's intrinsic 
pacing system until a permanent pacemaker can be implanted, or to 
control irregular heartbeats in patients following cardiac surgery or a 
myocardial infarction. * * *
* * * * *
0
4. Amend Sec.  870.5300 by revising the section heading to read as 
follows:


Sec.  870.5300  DC-defibrillator (including paddles).

* * * * *

PART 882--NEUROLOGICAL DEVICES

0
5. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
6. Amend Sec.  882.5870 by revising the second sentence in paragraph 
(a) to read as follows:


Sec.  882.5870  Implanted peripheral nerve stimulator for pain relief.

    (a) Identification. * * * The stimulator consists of an implanted 
receiver with electrodes that are placed around a peripheral nerve and 
an external transmitter for transmitting the stimulating pulses across 
the patient's skin to the implanted receiver.
* * * * *

PART 886--OPHTHALMIC DEVICES

0
7. The authority citation for 21 CFR part 886 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
8. Amend Sec.  886.1120 by revising the section heading to read as 
follows:


Sec.  886.1120  Ophthalmic camera.

* * * * *

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06826 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P

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