Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction, 53851 [2011-22107]

Download as PDF Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Proposed Rules internationally? What impacts, either positive or negative, would result from an alignment of NRC regulatory requirements and guidance with international standards? 8. Should licensees be required to monitor and report LDE for foreign workers and report the values upon request? Are there other impacts (e.g., operational, administrative, costs, etc.) that should be anticipated if the U.S. regulatory structure were to be different from that being used in other countries? 9. Are there any other NRC regulations and regulatory guidance that might need to be reviewed and revised as a result of ICRP recommendations in reducing the allowable dose to the lens of the eye? 10. How are licensees monitoring to demonstrate compliance with the existing dose limits for the lens of the eye? Dated at Rockville, Maryland, this 19th day of August 2011. For the Nuclear Regulatory Commission. Josephine M. Piccone, Director, Division of Intergovernmental Liaison and Rulemaking, Office of Federal and State Materials and Environmental Management Programs. [FR Doc. 2011–21900 Filed 8–29–11; 8:45 am] Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993–0002, 301–796–6216. SUPPLEMENTARY INFORMATION: In FR Doc. 2011–19959, appearing on page 48058, in the Federal Register of Monday, August 8, 2011, the following correction is made: 1. On page 48062, in the first column, under ‘‘XIII. References,’’ the first reference is corrected to read ‘‘1. Geiger, D.R., ‘‘FY 2003 and 2004 Unit Costs for the Process of Medical Device Review,’’ September 2005, https://www.fda.gov/ downloads/MedicalDevices/Device RegulationandGuidance/Overview/ MedicalDeviceUserFeeand ModernizationActMDUFMA/ucm 109216.’’ Dated: August 24, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–22107 Filed 8–29–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 203 BILLING CODE 7590–01–P [Docket No. FR–5461–P–01] RIN 2502–AJ01 DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Housing Administration (FHA): Suspension of Section 238(c) SingleFamily Mortgage Insurance in Military Impacted Areas Food and Drug Administration 21 CFR Part 870 Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of August 8, 2011 (76 FR 48058). The document proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the class III preamendments device: Cardiovascular permanent pacemaker electrode. The document was published with an incorrect Internet address for the first reference in the References section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and srobinson on DSK4SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 18:48 Aug 29, 2011 Jkt 223001 Office of the Assistant Secretary of Housing—Federal Housing Commissioner, HUD. ACTION: Proposed rule. AGENCY: [Docket No. FDA–2011–N–0505] This proposed rule would suspend FHA’s mortgage insurance program for military impacted areas under section 238(c) of the National Housing Act (Act). This single-family mortgage insurance program, established by regulation in 1977, has been significantly underutilized for the past several years. Additionally, these mortgage loans are insured under comparable terms and conditions as loans insured under HUD’s primary single-family mortgage insurance program under section 203(b) of the National Housing Act. Accordingly, those borrowers who would be served under section 238(c) of the Act are served equally well under the section 203(b) mortgage insurance program. The suspension of this mortgage insurance program is consistent with the President’s budget request for Fiscal Year 2012. SUMMARY: PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 DATES: 53851 Comment Due Date: October 31, 2011. Interested persons are invited to submit comments regarding this proposed rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Room 10276, Washington, DC 20410– 0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. 1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Room 10276, Washington, DC 20410–0001. 2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at https://www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the https://www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically. ADDRESSES: Note: To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule. No Facsimile Comments. Facsimile (FAX) comments are not acceptable. Public Inspection of Public Comments. All properly submitted comments and communications submitted to HUD will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202–708– 3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the toll-free Federal Relay Service at 800–877–8339. Copies of all comments submitted are available for inspection and downloading at https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Karin Hill, Director, Office of Single E:\FR\FM\30AUP1.SGM 30AUP1

Agencies

[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Proposed Rules]
[Page 53851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0505]


Effective Date of Requirement for Premarket Approval for 
Cardiovascular Permanent Pacemaker Electrode; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
proposed rule that appeared in the Federal Register of August 8, 2011 
(76 FR 48058). The document proposed to require the filing of a 
premarket approval application or a notice of completion of a product 
development protocol for the class III preamendments device: 
Cardiovascular permanent pacemaker electrode. The document was 
published with an incorrect Internet address for the first reference in 
the References section. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993-0002, 301-796-6216.

SUPPLEMENTARY INFORMATION: In FR Doc. 2011-19959, appearing on page 
48058, in the Federal Register of Monday, August 8, 2011, the following 
correction is made:
    1. On page 48062, in the first column, under ``XIII. References,'' 
the first reference is corrected to read ``1. Geiger, D.R., ``FY 2003 
and 2004 Unit Costs for the Process of Medical Device Review,'' 
September 2005, https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109216.''

    Dated: August 24, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-22107 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P
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