[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Rules and Regulations]
[Pages 32309-32311]
[FR Doc No: 2022-11551]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0425]
RIN 1625-AA00

Safety Zone; Corte Madera Channel, Larkspur, CA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within 150-feet of the overhead electrical
transmission lines crossing Corte Madera Channel in Larkspur, CA. The
safety zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by the transfer of overhead
transmission lines, which cross the channel, from one tower to another.
Unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the safety zone without the
permission of the Captain of the Port San Francisco or a designated
representative.

EFFECTIVE DATES: This rule is effective from 9 a.m. on May 31, 2022,
through 12:30 p.m. on June 10, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0425 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant William Harris, Sector San Francisco Waterways
Management Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive final
details for this project until May 17, 2022. It is impracticable to go
through the full notice and comment rule making process because the
Coast Guard must establish this safety zone by May 31, 2022, and lacks
sufficient time to provide a reasonable comment period and to consider
those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because action is
necessary to protect personnel, vessels, and the marine environment
from the potential safety hazards created by the transfer of electrical
transmission lines, which cross the Corte Madera Channel, from one
tower to a newly constructed one beginning on May 31, 2022.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port San
Francisco (COTP) has determined that potential hazards associated with
the transfer of the overhead electrical transmission lines, which cross
the Corte Madera Channel from one tower to a newly constructed one
starting May 31, 2022, will be a safety concern for anyone within a
150-feet on either side of the overhead transmission lines. For this
reason, this temporary safety zone is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
safety zone while the overhead lines are being transferred.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9 a.m. until 10 a.m.,
10:15 a.m. until 11:15 a.m., and 11:30 a.m. until 12:30 p.m. on each
day from May 31, 2022, through June 3, 2022, and each day from June 6,
2022, through June 10, 2022. The safety zone will cover all navigable
waters within 150-feet of a line connecting the following points:
37[deg]56'30.6'' N by 122[deg]30'19.7'' W to 37[deg]56'38.1'' N by
122[deg]30'16.8'' W. The duration of the zone is intended to protect
personnel, vessels, and the marine environment in these navigable
waters while the overhead lines are being transferred. No vessel or
person will be permitted to enter into, transit through, or remain in
the safety zone without obtaining permission from the COTP or a
designated representative. A ``designated representative'' means a
Coast Guard Patrol Commander, including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel, or a Federal,
State, or local officer designated by or assisting the COTP in the
enforcement of the safety zone.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited size,
location, duration, and time-of-day of the safety zone. This safety
zone will impact a small designated area of the Corte Madera Channel
for three, one-hour periods over eight days, with 24 fifteen-minute
windows designated to allow the safe transit of vessels, including
ferries, through the safety zone. Moreover, the Coast Guard will issue
a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone. Any vessels or persons desiring to transit through or around the
temporary safety zone may do so upon express permission from the COTP
or the COTP's designated representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their

fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
temporary safety zone lasting only three one-hour periods, daily over
eight days that will prohibit entry within 150-feet of a line
connecting the following points: 37[deg]56'30.6'' N by
122[deg]30'19.7'' W to 37[deg]56'38.1'' N by 122[deg]30'16.8'' W. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T11-097 to read as follows:

Sec.  165.T11-097  Safety Zone; Corte Madera Channel, Larkspur, CA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Corte Madera Channel, from surface to bottom, 150-feet on
either side of a line connecting the following points beginning at
37[deg]56'30.6'' N, 122[deg]30'19.7'' W, thence to 37[deg]56'38.1'' N,
122[deg]30'16.8'' W or as announced via Broadcast Notice to Mariners.
These coordinates are based on North American Datum 83 (NAD 83).
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel, or a Federal, State, and Local officer designated by or
assisting the Captain of the Port San Francisco (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) During the enforcement periods, the safety zone is closed to
all vessel traffic, except as may be permitted by the COTP or the
COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-23A or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Enforcement periods. This section will be enforced from 9 a.m.
until 10 a.m., 10:15 a.m. until 11:15 a.m., and

11:30 a.m. until 12:30 p.m. on each day from May 31, 2022, through June
3, 2022, and each day from June 6, 2022, through June 10, 2022.
    (e) Information broadcasts. The COTP or the COTP's designated
representative will notify the maritime community of periods during
which this zone will be enforced, in accordance with Sec.  165.7.

    Dated: May 24, 2022.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2022-11551 Filed 5-27-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11496-11497]
[FR Doc No: 2023-03771]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-281, OMB Control No. 3235-0316]

Proposed Collection; Comment Request; Extension: Form N-3

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    The title for the collection of information is ``Form N-3 (17 CFR
239.17a and 274.11b) under the Securities Act of 1933 (15 U.S.C. 77)
and under the Investment Company Act of 1940 (15 U.S.C. 80a),
Registration Statement of Separate Accounts Organized as Management
Investment Companies.'' Form N-3 is the form used by separate accounts
offering variable annuity contracts which are organized as management
investment companies to register under the Investment Company Act of
1940 (``Investment Company Act'') and/or to register their securities
under the Securities Act of 1933 (``Securities Act''). Form N-3 is also
the form used to file a registration statement under the Securities Act
(and any amendments thereto) for variable annuity contracts funded by
separate accounts which would be required to be registered under the
Investment Company Act as management investment companies except for
the exclusion provided by Section 3(c)(11) of the Investment Company
Act (15 U.S.C. 80a-3(c)(11)). Section 5 of the Securities Act (15
U.S.C. 77e) requires the filing of a registration statement prior to
the offer of securities to the

public and that the statement be effective before any securities are
sold, and Section 8 of the Investment Company Act (15 U.S.C. 80a-8)
requires a separate account to register as an investment company.
    Form N-3 also permits separate accounts offering variable annuity
contracts which are organized as investment companies to provide
investors with a prospectus and a statement of additional information
covering essential information about the separate account when it makes
an initial or additional offering of its securities. Section 5(b) of
the Securities Act requires that investors be provided with a
prospectus containing the information required in a registration
statement prior to the sale or at the time of confirmation or delivery
of the securities. The form also may be used by the Commission in its
regulatory review, inspection, and policy-making roles.
    Commission staff estimates that there will be 1 initial
registration statements over the nest three years and 6 insurer
separate accounts that file post-effective amendments on Form N-3 per
year, with an average of 3 investment options per post-effective
amendment. The Commission further estimates that the hour burden for
preparing and filing a post-effective amendment on Form N-3 is 157.55
hours per portfolio. The total annual hour burden for preparing and
filing post-effective amendments is 2,836 hours (6 post-effective
amendments x 3 investment options per post-effective amendment x 157.55
hours per portfolio). The estimated annual hour burden for preparing
and filing initial registration statements is 309 hours. The total
annual hour burden for Form N-3, therefore, is estimated to be 3,145
hours (2,836 hours + 309 hours). Respondents may rely on outside
counsel or auditors in connection with the preparation and filing of
Form N-3. Commission staff estimates that the annual cost burden
associated with preparing and filing Form N-3 is $139,696.
    The information collection requirements imposed by Form N-3 are
mandatory. Responses to the collection of information will not be kept
confidential. 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 control number.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by April 24, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: February 17, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-03771 Filed 2-22-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54340-54341]
[FR Doc No: 2018-23531]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

October 23, 2018.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-13-000.
    Applicants: Gateway Energy Storage, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5241.
    Comments Due: 5 p.m. ET 11/13/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-2340-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2018-10-23_SA 3153 Crescent Wind-
METC GIA (J538) Substitute Original to be effective 8/15/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5064.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-156-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP As-Available Capacity
Agreement Concurrence Filing to be effective 12/22/2018.
    Filed Date: 10/22/18.

    Accession Number: 20181022-5145.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-157-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-10-22_SA 3181 Glaciers
Edge-MidAmerican GIA (J506) to be effective 10/8/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5147.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-158-000.
    Applicants: Ambit Northeast, LLC.
    Description: Baseline eTariff Filing: Ambit Northeast LLC MBR
Application to be effective 10/22/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5198.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-159-000.
    Applicants: Southwestern Electric Power Company.
    Description: Sec.  205(d) Rate Filing: ETEC and NTEC PSA to be
effective 5/31/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5087.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-160-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Clean-up to OATT, Schedule
1A to add language previously accepted by FERC to be effective 1/1/
2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5203.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-161-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: Revisions to Permit Ex-Post
Refund of Cluster Participation Deposits to be effective 12/23/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5216.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-162-000.
    Applicants: Midcontinent Independent System Operator, Inc., ALLETE,
Inc.
    Description: Sec.  205(d) Rate Filing: 2018-10-23_SA 3191 MP-GRE T-
L IA (Tower Frazer) to be effective 10/24/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5235.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-163-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Cranell Wind Farm
Interconnection Agreement to be effective 10/12/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5254.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-164-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Midwest Energy Depreciation
Rates to be effective 1/1/2019.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5259.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-165-000.
    Applicants: Southwestern Electric Power Company.
    Description: Sec.  205(d) Rate Filing: ETEC and NTEC PSA to be
effective 5/31/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5269.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-166-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Tariff Revisions to
Accelerate the Process for Frequently Constrained Areas to be effective
12/22/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5271.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-167-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Chapman Ranch Wind I
System Upgrade Agreement Cancellation to be effective 10/10/2018.
    Filed Date: 10/23/18.
    Accession Number: 20181023-5272.
    Comments Due: 5 p.m. ET 11/13/18.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES19-1-000.
    Applicants: Kansas City Power & Light Company, KCP&L Greater
Missouri Operations Company, Kansas Gas and Electric Company, Westar
Energy, Inc.
    Description: Errata to October 3, 2018 Joint Application for
Authorization Under FPA Section 204 to Issue Short-Term Debt Securities
of Kansas City Power & Light Company, et al.
    Filed Date: 10/9/18.
    Accession Number: 20181009-5295.
    Comments Due: 5 p.m. ET 10/24/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 23, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-23531 Filed 10-26-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43093-43095]
[FR Doc No: 2015-17800]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0067]

Medical Device Patient Labeling; Request for Comments; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration is announcing the following
public workshop entitled ``Medical Device Patient Labeling''. The
purpose of the public workshop is to discuss issues associated with the
development and use of medical device

patient labeling including content, testing, use, access, human
factors, emerging media formats, and promotion and advertising. The
Center for Devices and Radiological Health (CDRH) is seeking input into
these topics from patients and advocacy groups, academic and
professional organizations, industry, standards organizations, and
governmental Agencies. Ideas generated during this workshop will help
facilitate development or revision of guidances and/or standards for
medical device patient labeling.
    Date and Time: The workshop will be held on September 29, 2015,
from 8 a.m. to 5 p.m. and September 30, 2015, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
    Contact Person: Antoinette (Tosia) Hazlett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>gov.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending the ``Medical
Device Patient Labeling'' public workshop must register online by 4
p.m. on September 21, 2015. Early registration is recommended because
facilities are limited and, therefore, FDA may limit the number of
participants from each organization. If time and space permit, onsite
registration on the days of the public workshop will be provided
beginning at 7 a.m. If you need special accommodations due to a
disability, please contact Susan Monahan at least 7 days in advance of
the meeting.
    To register for the public workshop, please visit CDRH's Workshops
and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public
workshop from the posted events list.) Please provide complete contact
information for each attendee, including name, title, affiliation,
email, and telephone number. Those without Internet access should
contact Susan Monahan to register (see Contact Person). Registrants
will receive confirmation after they have been accepted. You will be
notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 4 p.m. on September 21, 2015. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after September 25, 2015. If you have never attended
a Connect Pro event before, test your connections at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. (FDA has
verified the Web site addresses in this document, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
    Comments: FDA is holding this public workshop to obtain stakeholder
input on medical device patient labeling. In order to permit the widest
possible opportunity to obtain public comment, FDA is soliciting either
electronic or written comments on all aspects of the public workshop.
The deadline for submitting comments regarding this public workshop is
October 30, 2015.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
topics as outlined in ``Topics for Discussion'', please identify the
topic you are addressing. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at: http://www.regulations.gov. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

SUPPLEMENTARY INFORMATION:

I. Background

    The CDRH Guidance on Medical Device Patient Labeling (available at
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070782.htm) serves to assist manufacturers in
their development of patient labeling and to assist Center reviewers in
their review and evaluation of the manufacturers' labeling. Medical
device patient labeling includes any medical device information that is
intended for a lay audience. It is intended to help assure that the
device is used safely and effectively. This labeling may pertain to
therapeutic, restorative, diagnostic, or cosmetic devices. Medical
device patient labeling is supplied in many formats, for example: As
patient brochures, patient leaflets, user manuals, videos or audio
recording, and through physical or online media. This labeling is
intended to be supplied to or available to patients or their lay
caregivers for their use with or without accompanying professional
counseling. While some patients receive labeling from their healthcare
practitioners or device suppliers, others receive it in the packaging
of over-the-counter devices. CDRH is collecting public comment to use
in updating the Medical Device Patient Labeling Guidance.
    FDA is committed to supporting the development and availability of
patient labeling which supports the safe and effective use of medical
devices by patients. To inform FDA in their efforts, they are seeking
input on the topics identified in section II.

II. Topics for Discussion

    FDA seeks to address and receive comments on the following topics:

A. Current Medical Device Patient Labeling

    (1) The current use and practice trends of medical device patient
labeling development and use. For example: When is medical device
patient labeling used? How much medical device patient labeling exists?
How much modification and revision of existing medical device patient
labeling

occurs, and under what circumstances? What is the role of voluntary
consensus standards in developing medical device patient labeling?
    (2) What risks or adverse outcomes have been reported in
association with the use of medical device patient labeling? What
communication barriers have been encountered, and how can they be
mitigated?
    (3) Is there any part of the medical device patient labeling
development process that presents a barrier to receiving approval or
clearance from CDRH? If so, please provide examples of the specific
issues, how frequently this occurs, and suggestions which
constructively address these barriers.
    (4) What are the best ways to foster efficient networking with
patients and advocacy groups, academic and professional organizations,
industry, standards organizations, and government Agencies to address
medical device patient labeling needs?

B. Medical Device Patient Labeling Needs Assessment

    (1) Describe the parameters that should be used in determining
priority areas of development of medical device patient labeling,
including both therapeutic and diagnostic devices.
    (2) What are best practices for conducting a needs assessment of
medical device patient labeling?

C. Advancing Development

    (1) What could advance the development and use of medical device
patient labeling?
    (2) How should patient labeling be considered in the development
stages of all medical device labeling?
    (3) What resources (e.g., registries, industry, or patient advocacy
groups,) could be tapped to advance the development of medical device
patient labeling?
    (4) What are potential changes to guidances and regulations, or
advances in current science that may help develop and enhance medical
device patient labeling to address the needs of medical device
manufacturers, device suppliers, and device users?

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17800 Filed 7-20-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 28, 2008 (Volume 73, Number 168)]
[Notices]
[Page 50802-50803]
[DOCID:fr28au08-48]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13116-000; Project No. 13115-000]

Mississippi River 14 Hydro, LLC, BPUS Generation Development,
LLC; Notice of Competing Preliminary Permit Applications Accepted for
Filing and Soliciting Comment, Motions To Intervene, and Competing
Applications

August 21, 2008.
    On February 15, 2008, Mississippi River 14 Hydro, LLC and BPUS
Generation Development, LLC each filed a competing application,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Mississippi River Lock and Dam No. 14
Hydroelectric Project, to be located on the Mississippi River in Rock
Island County and Scott County, Illinois. The Mississippi Lock and Dam
14 is owned by the U.S. Army Corps of Engineers.
    Mississippi River 14 Hydro, LLC's proposed project would utilize
the existing U.S. Army Corps of Engineers' Mississippi Lock and Dam No.
14 and would consist of: (1) A proposed powerhouse containing three
generating units with an installed capacity of 26-megawatts; (2) a
switchyard; (3) a proposed 1-mile, 69-kV transmission line; and (4)
appurtenant facilities. The proposed Mississippi River Lock and Dam 14
Hydroelectric Project would have an estimated annual generation of
approximately 139-gigawatt-hours, which would be sold to a local
utility.
    BPUS Generation Development, LLC's proposed project would utilize
the U.S. Army Corps of Engineers' Mississippi River Lock and Dam No. 14
would consist of:(1) A proposed powerhouse containing five generating
units with a

combined installed capacity of 26-megawatts; (2) a new 13,100-foot-
long, 230-kilovolt transmission line; and (3) appurtenant facilities.
The proposed Mississippi River Lock and Dam No. 14 Hydroelectric
Project would have an average annual generation of 145-gigawatt-hours,
which would be sold to a local utility.
    Applicants Contacts: For Mississippi River 14 Hydro, LLC, Mr. Brent
L. Smith, COO, Symbiotics, LLC, P. O. Box 535, Rigby, ID 83442, phone:
(208) 745-0834. For BPUS Generation Development, LLC, Mr. Jeffrey M.
Auser, P.E., BPUS Generation Development, LLC, 225 Greenfield Parkway,
Suite 201, Liverpool, NY 13088,<PHONE_NUMBER>.
    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-13116
or P-13115) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-19934 Filed 8-27-08; 8:45 am]

BILLING CODE 6717-01-P