Domestic Licensing of Source Material-Amendments/Integrated Safety Analysis; Correction, 47085 [2011-19726]
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47085
Proposed Rules
Federal Register
Vol. 76, No. 150
Thursday, August 4, 2011
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
materials related to the proposed rule
and proposed draft guidance document
can be found at https://
www.regulations.gov by searching on
Docket ID NRC–2009–0079 for the
proposed rule and Docket ID NRC–
2011–0080 for the proposed draft
guidance document.
NUCLEAR REGULATORY
COMMISSION
Dated at Rockville, Maryland, this 29th day
of July 2011.
For the Nuclear Regulatory Commission.
Cindy Bladey,
Chief, Rules, Announcements and Directives
Branch, Division of Administrative Services,
Office of Administration.
10 CFR Part 40
[NRC–2009–0079 and NRC–2011–0080]
RIN 3150–AI50
[FR Doc. 2011–19726 Filed 8–3–11; 8:45 am]
Domestic Licensing of Source
Material—Amendments/Integrated
Safety Analysis; Correction
BILLING CODE 7590–01–P
Nuclear Regulatory
Commission.
ACTION: Extension of public comment
period and public meeting; correction.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is correcting a notice
appearing in the Federal Register on
July 27, 2011 (76 FR 44865), that
extended the public comment period
and provided a date for a public meeting
for the proposed rule, ‘‘Domestic
Licensing of Source Material—
Amendments/Integrated Safety
Analysis.’’ This action is necessary to
correct the date of the public meeting in
the DATES section, and to correct the
Docket ID information for accessing
publicly available documents related to
the proposed rule and draft guidance
document in the ADDRESSES section.
FOR FURTHER INFORMATION CONTACT:
Cindy Bladey, Chief, Rules,
Announcements and Directives Branch,
Office of Administration, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 301–492–
3667 or e-mail: Cindy.Bladey@nrc.gov.
SUPPLEMENTARY INFORMATION: On page
44865 of Federal Register document
2011–14060, published July 27, 2011
(76 FR 44865), in the third column,
under the section titled DATES, second
paragraph, ‘‘August 7, 2011’’ is
corrected to read ‘‘August 17, 2011.’’
Also, on page 44866 of the same
document, in the first column, the last
bulleted item before the section titled
FOR FURTHER INFORMATION CONTACT is
removed and the following bulleted
item is added in its place:
• Federal Rulemaking Web site:
Public comments and supporting
rmajette on DSK89S0YB1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
15:20 Aug 03, 2011
Jkt 223001
wishes to continue to market the device
will need to submit a PMA within 90
days of the effective date of the final
rule. Please see section XII of this
document for the effective date of any
final rule that may publish based on this
proposal.
You may submit comments,
identified by [Docket No. FDA–2011–N–
0526], by any of the following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2011–N–0526]
Effective Date of Requirement for
Premarket Approval for a Pacemaker
Programmer
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
require the filing of a premarket
approval application (PMA) or a notice
of completion of a product development
protocol (PDP) for the class III
preamendments device pacemaker
programmers. The agency is also
summarizing its proposed findings
regarding the degree of risk of illness or
injury designed to be eliminated or
reduced by requiring this device to meet
the statute’s approval requirements and
the benefits to the public from the use
of the devices. In addition, FDA is
announcing the opportunity for
interested persons to request that the
agency change the classification of the
aforementioned device based on new
information. This action implements
certain statutory requirements.
DATES: Submit either electronic or
written comments by November 2, 2011.
Submit requests for a change in
classification by August 19, 2011. FDA
intends that, if a final rule based on this
proposed rule is issued, anyone who
SUMMARY:
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
Docket Number and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the Comments heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
Search box and follow the prompts and/
or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Elias Mallis, Food and Drug
Administration, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538,
Silver Spring, MD 20993, 301–796–
6216.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04AUP1.SGM
04AUP1
Agencies
[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Proposed Rules]
[Page 47085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19726]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 /
Proposed Rules
[[Page 47085]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 40
[NRC-2009-0079 and NRC-2011-0080]
RIN 3150-AI50
Domestic Licensing of Source Material--Amendments/Integrated
Safety Analysis; Correction
AGENCY: Nuclear Regulatory Commission.
ACTION: Extension of public comment period and public meeting;
correction.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is correcting a
notice appearing in the Federal Register on July 27, 2011 (76 FR
44865), that extended the public comment period and provided a date for
a public meeting for the proposed rule, ``Domestic Licensing of Source
Material--Amendments/Integrated Safety Analysis.'' This action is
necessary to correct the date of the public meeting in the DATES
section, and to correct the Docket ID information for accessing
publicly available documents related to the proposed rule and draft
guidance document in the ADDRESSES section.
FOR FURTHER INFORMATION CONTACT: Cindy Bladey, Chief, Rules,
Announcements and Directives Branch, Office of Administration, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone:
301-492-3667 or e-mail: Cindy.Bladey@nrc.gov.
SUPPLEMENTARY INFORMATION: On page 44865 of Federal Register document
2011-14060, published July 27, 2011 (76 FR 44865), in the third column,
under the section titled DATES, second paragraph, ``August 7, 2011'' is
corrected to read ``August 17, 2011.'' Also, on page 44866 of the same
document, in the first column, the last bulleted item before the
section titled FOR FURTHER INFORMATION CONTACT is removed and the
following bulleted item is added in its place:
Federal Rulemaking Web site: Public comments and
supporting materials related to the proposed rule and proposed draft
guidance document can be found at https://www.regulations.gov by
searching on Docket ID NRC-2009-0079 for the proposed rule and Docket
ID NRC-2011-0080 for the proposed draft guidance document.
Dated at Rockville, Maryland, this 29th day of July 2011.
For the Nuclear Regulatory Commission.
Cindy Bladey,
Chief, Rules, Announcements and Directives Branch, Division of
Administrative Services, Office of Administration.
[FR Doc. 2011-19726 Filed 8-3-11; 8:45 am]
BILLING CODE 7590-01-P