[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Rules and Regulations]
[Page 30299]
[DOCID:fr01jn10-16]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0374]

Drawbridge Operation Regulations; Fox River, Green Bay, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: Commander, Ninth Coast Guard District, has issued a temporary
deviation from the regulation governing the operation of the Main
Street Bridge at Mile 1.21 over the Fox River, at Green Bay, WI. This
deviation will temporarily change the operating schedule of the bridge
to accommodate the 2010 Tall Ships event in the city of Green Bay, WI.
This temporary deviation allows the bridge to open once an hour on the
hour for recreational vessels and commercial vessels less than 300
gross tons. The bridge will open on demand at all times for public
vessels, tugs, and commercial vessels 300 gross tons or greater.

DATES: This deviation is effective from August 13, 2010 through August
15, 2010 between the hours of 9 a.m. and 5 p.m. daily.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0374 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0374 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Lee D. Soule, Bridge Management Specialist, Ninth
Coast Guard District; telephone<PHONE_NUMBER>, e-mail;
<EMAIL_ADDRESS>If you have questions on viewing the docket, call
Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION: The City of Green Bay, Wisconsin, who owns
and operates this drawbridge, has requested a temporary deviation from
the current operating regulations set forth in 33 CFR 117.1087 to
facilitate efficient management of all transportation needs and provide
timely public safety services during this special event. In accordance
with 33 CFR 117.35(e), the drawbridge must return to its regular
operating schedule immediately at the end of the designated time
period. This deviation from the operating regulations is authorized
under 33 CFR 117.35.

    Dated: May 10, 2010.
F.M. Midgette,
Acting Captain, Commander, Ninth Coast Guard District, U.S. Coast
Guard.
[FR Doc. 2010-12977 Filed 5-28-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Pages 46023-46024]
[FR Doc No: 2019-18929]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2837]

Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance Environment; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of August 2, 2019. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Testing and Labeling Medical Devices for Safety in
the Magnetic Resonance (MR) Environment.'' The Agency is taking this
action in response to a request for an extension to allow interested
persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published
August 2, 2019 (84 FR 37886). Submit either electronic or written
comments on the draft guidance by October 31, 2019, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-2837 for ``Testing and Labeling Medical Devices for Safety
in the Magnetic Resonance (MR) Environment; Draft Guidance for Industry
and Food and Drug Administration Staff.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Terry Woods, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2116, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 2, 2019, FDA published a notice
of availability with a 60-day comment period to request comments on the
draft guidance for industry and FDA staff entitled ``Testing and
Labeling Medical Devices for Safety in the Magnetic Resonance (MR)
Environment.''
    The Agency has received a request for a 30-day extension of the
comment period. The request conveyed concern that the current 60-day
comment period does not allow sufficient time to develop a meaningful
or thoughtful response.
    FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until October 31, 2019. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.

II. Significance of Guidance

    FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Testing and Labeling Medical Devices for Safety in
the Magnetic Resonance (MR) Environment'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1500059 to identify the
guidance you are requesting.

    Dated: August 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18929 Filed 8-30-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11451-11453]
[FR Doc No: 2011-4652]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-0801; FRL-9273-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Residential Lead-Based Paint
Hazard Disclosure Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that the following Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval: Residential Lead-Based Paint
Hazard Disclosure Requirements; EPA ICR No. 1710.06, OMB No. 2070-0151.
The ICR, which is abstracted below, describes the nature of the
information collection activity and its expected burden and costs.

DATES: Additional comments may be submitted on or before April 1, 2011.

ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2010-0801 to (1) EPA online using www.regulations.gov (our
preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to:
Document Control Office (DCO), Office of Pollution Prevention and
Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Pamela Myrick, Acting Director,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Mail code: 7408-M, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 27, 2010 (75 FR 66087), EPA sought comments on this
renewal ICR. EPA sought comments on this ICR pursuant to 5 CFR
1320.8(d). EPA received no comments during the comment period. Any
comments related to this ICR should be submitted to EPA and OMB within
30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA EPA-HQ-OPPT-2010-0801, which is available for online viewing at
http://www.regulations.gov, or in person inspection at the OPPT Docket
in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Reading Room is
202-566-1744, and the telephone number for the Pollution Prevention and
Toxics Docket is<PHONE_NUMBER>. Use http://www.regulations.gov to submit
or view public comments, access the index listing of the contents of
the public docket, and to access those documents in the public docket
that are available electronically. Once in the system, select
``search,'' then key in the docket ID number identified above.
    EPA's policy is that public comments, whether submitted
electronically or in paper, will be made available for public viewing
in http://www.regulations.gov as EPA receives them and without change,
unless the comment contains copyrighted material, confidential business
information (CBI), or other information whose public disclosure is
restricted by statute. When EPA identifies a comment containing
copyrighted material, EPA will provide a reference to that material in
the version of the comment that is placed in http://www.regulations.gov. The entire printed comment, including the
copyrighted material, will be available in the public docket. Although
identified as an item in the official docket, information claimed as
CBI, or whose disclosure is otherwise restricted by statute, is not
included in the official public docket, and will not be available for
public viewing in http://www.regulations.gov. For further information
about the electronic docket, go to http://www.regulations.gov.
    Title: Residential Lead-Based Paint Hazard Disclosure Requirements.
    ICR Status: This is a request to renew an existing approved
collection. This ICR is scheduled to expire on March 31, 2011. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB.
    Abstract: Section 1018 of the Residential Lead-Based Paint Hazard
Reduction Act of 1992 (42 U.S.C. 4852d) requires that sellers and
lessors of most residential housing built before 1978 disclose known
information on the presence of lead-based paint and lead-based paint
hazards, and provide an EPA-approved pamphlet to purchasers and renters
before selling or leasing the housing. Sellers of pre-1978 housing are
also required to provide prospective purchasers with 10 days to conduct
an inspection or risk assessment for lead-based paint hazards before
obligating purchasers under contracts to purchase the property. The
rule does not apply to rental housing that has been found to be free of
lead-based paint, zero-bedroom dwellings, housing for the elderly,
housing for the handicapped or short-term leases. This information
collection addresses the information collection-related requirements
related to each affected party as described below.
    1. Sellers of pre-1978 residential housing. Sellers of pre-1978
housing must attach certain notification and disclosure language to
their sales/leasing contracts. The attachment lists the information
disclosed and acknowledges compliance by the seller, purchaser and any
agents involved in the transaction.
    2. Lessors of pre-1978 residential housing. Lessors of pre-1978
housing must attach notification and disclosure language to their
leasing contracts. The attachment, which lists the information
disclosed and acknowledges compliance with all elements of the rule,
must be signed by the lessor, lessee and any agents acting on their
behalf. Agents and lessors must retain the information for three years
from the completion of the transaction.
    3. Agents acting on behalf of sellers or lessors. Section 1018 of
the Residential Lead-Based Paint Hazard Reduction Act of 1992
specifically directs EPA and HUD to require agents acting on behalf of
sellers or lessors to ensure compliance with the disclosure
regulations.
    Responses to the collection of information are mandatory (see 40
CFR part 745, Subpart F, and 24 CFR part 35, Subpart H). Respondents
may claim all or part of a notice as CBI. EPA will disclose information
that is covered by a CBI claim only to the extent permitted by, and in
accordance with, the procedures in 40 CFR part 2.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9 and included on the related
collection instrument or form, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average about
0.18 hours per response. Burden means the total time, effort or
financial resources expended by persons to generate, maintain, retain
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install and utilize technology and systems for the purposes of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
    Respondents/Affected Entities: Entities potentially affected by
this action are persons engaged in selling, purchasing or leasing
certain residential dwellings built before 1978, or who are real estate
agents representing such parties.

    Frequency of Collection: On occasion.
    Estimated average number of responses for each respondent: 1.
    Estimated No. of Respondents: 39,124,000.
    Estimated Total Annual Burden on Respondents: 6,937,330 hours.
    Estimated Total Annual Costs: $126,120,374.
    Changes in Burden Estimates: This request reflects a decrease of
807,286 hours (from 7,744,616 hours to 6,937,330 hours) in the total
estimated respondent burden from that currently in the OMB inventory.
This decrease reflects a reduction in the estimated annual number of
real estate sales and residential property rentals involving target
housing subject to the rule's requirements and an overall decrease in
estimated real estate sales. The Supporting Statement provides details
on the change in burden estimate. The change is an adjustment.

    Dated: February 23, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-4652 Filed 3-1-11; 8:45 am]
BILLING CODE 6560-50-P