[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7871-7872]
[FR Doc No: 2011-3042]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-1020; OMB Control Number: 1625-0108]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0108,
Standard Numbering System for Undocumented Vessels. Our ICR describes
the information we seek to collect from the public. Review and comments
by OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before March
14, 2011.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2010-1020] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) and/or to OIRA. To avoid
duplicate submissions, please use only one of the following means:
    (1) Online: (a) To Coast Guard docket at http://www.regulations.gov. (b) To OIRA by e-mail via<EMAIL_ADDRESS>    (2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001. (b) To
OIRA, 725 17th Street, NW., Washington, DC 20503, attention Desk
Officer for the Coast Guard.
    (3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
202-366-9329.
    (4) Fax: (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov.

Additionally, copies are available from: COMMANDANT (CG-611), ATTN:
PAPERWORK REDUCTION ACT MANAGER, U.S. COAST GUARD, 2100 2ND ST, SW.,
STOP 7101, WASHINGTON, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Contact Ms. Kenlinishia Tyler, Office
of Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collections; (2) the accuracy of the estimated burden of the
collection; (3) ways to enhance the quality, utility, and clarity of
information subject to the collection; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG 2010-1020], and must be received by March 14,
2011. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2010-1020], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an e-mail address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES, but please
submit them by only one means. To submit your comment online, go to
http://www.regulations.gov, and type ``USCG-2010-1020'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Keyword'' box insert ``USCG-2010-1020'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: USCG-2010-0978.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (75 FR 70938, November 19,
2010) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments.

Information Collection Request

    Title: Standard Numbering System for Undocumented Vessels.
    OMB Control Number: 1625-0108.
    Type of Request: Extension of a previously approved collection.
    Respondents: Owners of all undocumented vessels propelled by
machinery. ``Owners'' may include individuals or households, non-profit
organizations, and small businesses (e.g., liveries that offer
recreational vessels for rental by the public) or other for-profit
organizations.
    Abstract: The Standard Numbering System (SNS) collects information
on undocumented vessels and vessel owners operating on waters subject
to the jurisdiction of the United States. Federal, State, and local law
enforcement agencies use information daily or as warranted from the
system for enforcement of boating laws or theft and fraud
investigations. Since the September 11, 2001 terrorist attacks on the
United States, the need has increased for identification of
undocumented vessels to meet port security and other missions to
safeguard the homeland.
    Forms: None.
    Burden Estimate: The estimated burden remains the same at 286,458
hours a year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: February 7, 2011.
D.M. Dermanelian,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2011-3042 Filed 2-10-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 6, 2006 (Volume 71, Number 43)]
[Notices]
[Page 11193-11194]
[DOCID:fr06mr06-30]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

February 27, 2006.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER05-597-000.
    Applicants: Wayne-White Counties Electric Cooperative.
    Description: Wayne-White Counties Electric Cooperative submits the
negotiated settlement in its proceeding involving its OATT.
    Filed Date: February 17, 2006.
    Accession Number: 20060221-0188.
    Comment Date: 5 p.m. eastern time on Friday, March 10, 2006.

    Docket Numbers: ER06-262-001.
    Applicants: Pittsfield Generating Company, L.P.
    Description: Pittsfield Generating Co, LP submits its response
together with supporting materials, to the deficiency letter issued on
January 23, 2006.
    Filed Date: February 16, 2006.
    Accession Number: 20060221-0031.
    Comment Date: 5 p.m. eastern time on Thursday, March 9, 2006.

    Docket Numbers: ER06-508-001.
    Applicants: Southern Company Services, Inc.
    Description: Southern Company Services, Inc acting as agent for
Alabama Power Co et al submits Substitute Original Sheet 141B.168 to
FERC Electric Tariff, 4th Revised Volume No. 5 in accordance with Order
2006-A & 661-A.
    Filed Date: February 16, 2006.
    Accession Number: 20060221-0008.
    Comment Date: 5 p.m. eastern time on Thursday, March 9, 2006.

    Docket Numbers: ER06-647-000.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc and New England Power Pool
submits amendments to the ISO Financial Assurance Policy for Market
Participants Committee.
    Filed Date: February 16, 2006.
    Accession Number: 20060221-0084.
    Comment Date: 5 p.m. eastern time on Thursday, March 9, 2006.

    Docket Numbers: ER06-648-000.
    Applicants: Duke Energy St. Francis LLC.
    Description: Duke Energy St. Francis LLC submits its Notice of
Cancellation (Attachment A) to cancel its market-based rate tariff,
currently designated as FERC Electric Tariff, Original Volume No. 1.
    Filed Date: February 17, 2006.
    Accession Number: 20060221-0012.
    Comment Date: 5 p.m. eastern time on Friday, March 10, 2006.

    Docket Numbers: ER06-649-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits an unexecuted
interconnection service agreement etc with East Coast Power, LLC and
Public Service Electric and Gas Co.
    Filed Date: February 16, 2006.
    Accession Number: 20060221-0013.
    Comment Date: 5 p.m. eastern time on Thursday, March 9, 2006.

    Docket Numbers: ER06-650-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection LLC submits an interconnection
service agreement among PJM, Calvert Cliffs Nuclear Power Plant Inc,
and Baltimore Gas and Electric Co.
    Filed Date: February 17, 2006.
    Accession Number: 20060222-0012.
    Comment Date: 5 p.m. eastern time on Friday, March 10, 2006.

    Docket Numbers: ER06-651-000.
    Applicants: Ohio Valley Electric Corporation.
    Description: Ohio Valley Electric Corp submits notice of
cancellation of transmission agreement, transmission scheduling
agreement & lease with Louisville Gas & Electric Co.
    Filed Date: February 17, 2006.
    Accession Number: 20060222-0013.
    Comment Date: 5 p.m. eastern time on Friday, March 10, 2006.

    Docket Numbers: ER06-652-000.
    Applicants: PECO Energy Company.
    Description: PECO Energy Co submits a Notice of Cancellation of the
Interconnection Agreement with Exelon Generation for the Eddystone
Generating Facility.
    Filed Date: February 17, 2006.
    Accession Number: 20060222-0014.
    Comment Date: 5 p.m. eastern time on Friday, March 10, 2006.

    Docket Numbers: ER94-1478-018.
    Applicants: Electrade Corporation.
    Description: Electrade Corp submits an amendment to its market-
based rate schedule.
    Filed Date: February 16, 2006.
    Accession Number: 20060221-0004.
    Comment Date: 5 p.m. eastern time on Thursday, March 9, 2006.

    Docket Numbers: ER96-2495-028; ER97-4143-016; ER97-1238-023; ER98-
2075-022; ER98-542-018; EL04-131-000.
    Applicants: AEP Power Marketing, Inc.; AEP Service Corporation; CSW
Power Marketing, Inc.; CSW Energy Services, Inc.; Central and South
West Services, Inc.

    Description: American Electric Power Service Corp, on behalf of the
AEP Power Marketing Inc et al submits on February 13, 2006 an Offer of
Settlement and two related Settlement Agreements; on February 14, 2006
submits Certificate of Service.
    Filed Date: February 13, 2006.
    Accession Number: 20060223-0094.
    Comment Date: 5 p.m. eastern time on Monday, March 6, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3081 Filed 3-3-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2045-2049]
[FR Doc No: 2022-00492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 1270

[Docket No. FDA-2020-N-1519]
RIN 0910-AI41

Revocation of the Regulations for Human Tissue Intended for
Transplantation and Human Dura Mater

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to revoke the regulations for human tissue
intended for transplantation and human dura mater recovered prior to
May 25, 2005. The revocation does not affect the regulations for human
cells, tissues, and cellular and tissue-based products (HCT/Ps)
recovered on or after May 25, 2005. The rule is being finalized because
these regulations are obsolete or no longer necessary to achieve public
health goals.

DATES: This rule is effective February 14, 2022.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the

docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Need for Regulation/History of Rulemaking
    C. Applicability of Sec.  882.5975 and Part 1270
    D. Comments to the Proposed Rule
III. Legal Authority
IV. Effective Date
V. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

I. Executive Summary

A. Purpose of the Final Rule

    FDA is removing the regulations under part 1270 (21 CFR part 1270),
``Human Tissue Intended for Transplantation'' and Sec.  882.5975 (21
CFR 882.5975), ``Human dura mater.'' These regulations apply to certain
tissues recovered prior to May 25, 2005. The Agency does not believe
there are currently any tissues intended for transplantation remaining
in inventory that were recovered prior to this date and that would be
subject to these regulations. Therefore, the regulations under this
part are outdated and obsolete. All HCT/Ps recovered on or after May
25, 2005, are subject to the regulations under part 1271 (21 CFR part
1271), ``Human Cells, Tissues, and Cellular and Tissue-Based
Products.''

B. Summary of the Major Provisions of the Final Rule

    The final rule removes part 1270, ``Human Tissue Intended for
Transplantation,'' which applies to certain human tissue and to
establishments or persons engaged in the recovery, screening, testing,
processing, storage, or distribution of human tissue. It also removes
Sec.  882.5975, ``Human dura mater,'' which identifies and classifies
human dura mater recovered prior to May 25, 2005.

C. Legal Authority

    FDA is taking this action under the communicable disease provisions
of the Public Health Service Act (the PHS Act) and the device
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

D. Costs and Benefits

    Because this final rule will not impose any additional burden on
the industry, this regulation is not anticipated to result in any
compliance costs and the economic impact is expected to be minimal.

II. Background

A. Introduction

    FDA is issuing a final rule to revoke the regulations for human
tissue intended for transplantation (part 1270) and human dura mater
(Sec.  882.5975) recovered prior to May 25, 2005, because these
regulations are obsolete or no longer necessary to achieve public
health goals. The revocation does not affect the regulations for human
cells, tissues, and cellular and tissue-based products (HCT/Ps)
recovered on or after May 25, 2005.

B. Need for Regulation/History of Rulemaking

    FDA regulates articles containing or consisting of human cells or
tissues intended for implantation, transplantation, infusion, or
transfer into a human recipient. These are defined in Sec.  1271.3(d)
(21 CFR 1271.3(d)) as HCT/Ps. Tissues as defined in Sec.  1270.3(j) (21
CFR 1270.3(j)) recovered prior to May 25, 2005, are regulated under
part 1270. HCT/Ps recovered on or after May 25, 2005, are subject to
the regulations in part 1271. Examples of HCT/Ps include, but are not
limited to the following: Bone, ligament, skin, cornea, dura mater,
heart valve, hematopoietic stem/progenitor cells derived from
peripheral and cord blood, and semen or other reproductive tissue.
Vascularized human organs for transplantation are not considered HCT/
Ps. FDA previously regulated human dura mater recovered prior to May
25, 2005, under Sec.  882.5975 subject to special controls and
premarket notification.\1\
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    \1\ The special controls for human dura matter recovered prior
to May 25, 2005, can be found in ``Class II Special Controls
Guidance Document: Human Dura Mater--Guidance for Industry and FDA
Staff'', available at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-guidance-document-human-dura-mater-guidance-industry-and-fda-staff.
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    In the Federal Register of December 14, 1993 (58 FR 65514), FDA
published an interim rule (1993 interim rule) for human tissue intended
for transplantation. This rule provided specific donor suitability and
testing requirements for certain tissue products. As the use of human
tissue for transplantation increased, FDA determined that there was a
need for a much more comprehensive set of regulatory requirements that
included a broader scope of products. In the Federal Register of July
29, 1997 (62 FR 40429), FDA issued a final rule that clarified and
modified provisions of the 1993 interim rule.
    In the Federal Register of March 4, 1997 (62 FR 9721), FDA
announced the availability of a document entitled ``Proposed Approach
to the Regulation of Cellular and Tissue-Based Products'' that detailed
how cellular and tissue-based products would be regulated with a tiered
approach based on risk and the necessity for FDA review.
    As part of this approach, FDA advanced three regulatory proposals
including: (1) Registration and listing; (2) communicable-disease
screening and testing; and (3) processing standards. FDA published
three final rules to implement the proposed approach, which are
codified in part 1271 as follows: (1) ``Human Cells, Tissues, and
Cellular and Tissue-Based Products; Establishment Registration and
Listing'' (66 FR 5447, January 19, 2001); (2) ``Eligibility
Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products'' (69 FR 29786, May 25, 2004); and (3) ``Current
Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-
Based Product Establishments, Inspection and Enforcement'' (69 FR
68611, November 24, 2004).
    FDA issued these regulations to increase the safety of HCT/Ps, and
public confidence in their safety, by helping to prevent the
introduction, transmission, and spread of communicable disease. The
regulations were issued to protect the public health while minimizing
regulatory burden, which in turn would encourage significant
innovation.

C. Applicability of Sec.  882.5975 and Part 1270

    The Agency did not revoke part 1270 at the same time the Agency
proposed part 1271 because it would have been

impractical to apply part 1271 retroactively to human tissue, as
defined in Sec.  1270.3(j), that was recovered before the effective
date of the final rule. Instead, the Agency decided that human tissue,
as defined in Sec.  1270.3(j), that was recovered prior to May 25,
2005, would remain subject to the regulations in part 1270. However, in
the final rules applicable to HCT/Ps (66 FR 5447 at 5448; 69 FR 68611),
FDA noted its intention to revoke part 1270 in the future when we were
confident that there was no human tissue regulated under part 1270
available for use.
    Part 1270 applies only to human tissue defined in Sec.  1270.3(j)
and recovered prior to May 25, 2005. The device classification set
forth in Sec.  882.5975, ``Human dura mater,'' is only applicable to
human dura mater recovered prior to May 25, 2005. Human dura mater
recovered on or after May 25, 2005, is subject to the regulations in
part 1271 when an establishment does not qualify for any of the
exceptions in 21 CFR 1271.15. Further, human dura mater is regulated
solely under section 361 of the PHS Act (42 U.S.C. 264) and part 1271
when the HCT/P meets all the criteria set out in 21 CFR 1271.10(a).
Otherwise the HCT/P is regulated as a drug, device, and/or biological
product under the FD&C Act, and/or section 351 of the PHS Act (42
U.S.C. 262), and applicable regulations, including part 1271.
    Products that meet the definition of an HCT/P in Sec.  1271.3(d)
that are recovered on or after May 25, 2005, including those that have
been regulated after May 25, 2005, as drugs, devices, and/or biological
products under section 351 of the PHS Act and/or the FD&C Act will not
be affected by revocation of part 1270.
    We do not believe there are currently any tissues intended for
transplantation remaining in inventory that were recovered prior to May
25, 2005, that would be subject to these regulations. Therefore, the
regulations under Sec.  882.5975 and its accompanying special control
guidance, and the regulations under part 1270 are outdated and
obsolete.

D. Comments to the Proposed Rule

    In the Federal Register of December 21, 2020 (85 FR 82990), FDA
published a proposed rule entitled ``Revocation of the Regulations for
Human Tissue Intended for Transplantation and Human Dura Mater'' to
revoke the regulations for human tissue intended for transplantation
and human dura mater recovered prior to May 25, 2005. We did not
receive any comments on the proposed rule. Therefore, we are finalizing
the proposed rule without change.

III. Legal Authority

    FDA is issuing this final rule under the communicable disease
provisions of the PHS Act, which provide FDA with the authority to
issue and enforce regulations designed to prevent the introduction,
transmission, and spread of communicable disease (42 U.S.C. 216, 243,
264, and 271), and provisions of the FD&C Act applicable to devices (21
U.S.C. 351, 360, 360c, 360e, 360j, 360l, and 371)).

IV. Effective Date

    This final rule will become effective 30 days after the date of its
publication in the Federal Register.

V. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the rule will not create new regulatory
responsibilities for small entities, we certify that the rule will not
have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    This final rule will remove the obsolete regulations under part
1270 for human tissue intended for transplantation into a human
recipient and Sec.  882.5975 for human dura matter. These regulations
only apply to certain tissue derived from a human body and recovered
prior to May 25, 2005. We believe it is highly unlikely any such human
tissues remain available for use today. The final rule, therefore, is
not anticipated to result in any compliance costs to the industry. We
expect the economic impact on FDA resulting from removing an obsolete
regulation to be minimal.
    Table 1 summarizes the estimated benefits and costs of the final
rule. Annualized over 10 years, the estimated benefits (i.e. cost
savings) of the final rule will be $0 at both the 3 and 7 percent
discount rate. The present value of the estimated benefits (i.e., cost
savings) of the final rule will also be $0 at both the 3 and 7 percent
discount rate. The annualized costs of the final rule will be $0 at
both 3 and 7 percent discount rate. The present value of costs of the
final rule will also be $0 at both 3 and 7 percent discount rate.

                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                               ------------------------------------
                 Category                     Primary       Low        High                               Period                    Notes
                                             estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year...          $0          $0          $0        2020           7          10
                                                     0           0           0        2020           3          10
    Annualized Quantified.................  ..........  ..........  ..........  ..........  ..........  ..........
                                           -------------------------------------------------------------------------------------------------------------

    Qualitative...........................  Field investigators will no longer
                                            need to reference the obsolete
                                            regulations, resulting in very
                                            minor cost savings for FDA in
                                            terms of employee time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year...           0           0           0        2020           7          10
                                                     0           0           0        2020           3          10
    Annualized Quantified.................  ..........  ..........  ..........  ..........           7  ..........
                                            ..........  ..........  ..........  ..........           3  ..........
Qualitative...............................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/ ..........  ..........  ..........  ..........           7  ..........
     year.
                                            ..........  ..........  ..........  ..........           3  ..........
                                           -------------------------------------------------------------------------------------------------------------
    From/To...............................  From:
                                            To:
                                           -------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/   ..........  ..........  ..........  ..........           7  ..........
     year.
                                            ..........  ..........  ..........  ..........           3  ..........
                                           -------------------------------------------------------------------------------------------------------------
                                            From/To
                                            From:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.............................................................................................................
    Small Business: None................................................................................................................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has examined the economic implications of the rule as required
by the Regulatory Flexibility Act. If a rule will have a significant
economic impact on a substantial number of small entities, the
Regulatory Flexibility Act requires us to analyze regulatory options
that would lessen the economic effect of the rule on small entities.
This rule will not impose any new burdens on small entities, and thus
will not impose a significant economic impact on a substantial number
of small entities.
    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(h) that this action 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.

VII. Paperwork Reduction Act of 1995

    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.

VIII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13175. We have determined that the rule
does not contain policies that have substantial direct effects 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.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.

X. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA, Final Regulatory Impact Analysis; Final Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis,
Revocation of the Regulations for Human Tissue Intended for
Transplantation; Final Rule. Also available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

List of Subjects

21 CFR Part 882

    Medical devices.

21 CFR Part 1270

    Communicable diseases, HIV/AIDS, Reporting and recordkeeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food

and Drugs, 21 CFR parts 882 and 1270 are amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

Sec.  882.5975   [Removed]

0
2. Remove Sec.  882.5975.

PART 1270--[REMOVED]

0
3. Under the authority of 42 U.S.C. 216, 243, 264, 271, part 1270 is
removed.

    Dated: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00492 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60957-60958]
[FR Doc No: 2011-25194]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65400; File No. SR-NYSEArca-2011-53]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of a Proposed Rule Change To Reflect a Change to the Benchmark
Index Applicable to the Russell Equity ETF

September 26, 2011.

I. Introduction

    On August 3, 2011, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
reflect a change to the benchmark index applicable to the Russell
Equity ETF (``Fund,'' formerly known as the ``One Fund''). The proposed
rule change was published for comment in the Federal Register on August
24, 2011.\3\ The Commission received no comments on the proposal. This
order grants approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65161 (August 18,
2011), 76 FR 53004 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The Commission previously approved the listing and trading on the
Exchange of shares (``Shares'') of ``One Fund,'' a series of U.S. One
Trust, under NYSE Arca Equities Rule 8.600, which governs the listing
and trading of Managed Fund Shares.\4\ On February 23, 2011, Frank
Russell Company (``Russell'') acquired U.S. One, Inc., the previous
investment adviser for the Fund, and the Fund's investment adviser
became Russell Investment Management Company (``Adviser'').\5\ In
addition, as of April 15, 2011, the name of ``One Fund'' was changed to
Russell Equity ETF, and the name of U.S. One Trust was changed to
Russell Exchange Traded Funds Trust (``Trust''). Further, on or about
May 2, 2011, the custodian, transfer agent, and administrator for the
Fund changed from The Bank of New York to State Street Bank and Trust
Company. These administrative changes were implemented as a result of
the acquisition by Russell of U.S. One, Inc. The Exchange states that
the shareholders of the Fund were notified of the changes to the Fund's
name, the Trust's name, the Fund's investment adviser, and the
custodian, transfer agent, and administrator in the updated Fund
prospectus, dated April 29, 2011, included in the Fund's annual
prospectus mailing to shareholders.\6\ In this proposed rule change,
the Exchange proposes to reflect a change to the benchmark index
applicable to the Fund.\7\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 61843 (April 5,
2010), 75 FR 18558 (April 12, 2010) (SR-NYSEArca-2010-12) (``One
Fund Order''). See also Securities Exchange Act Release No. 61689
(March 11, 2010), 75 FR 13181 (March 18, 2010) (SR-NYSEArca-2010-12)
(``One Fund Notice,'' and together with the One Fund Order,
collectively, the ``One Fund Release'').
    \5\ The Exchange represents that the Adviser is affiliated with
multiple broker-dealers and has implemented a ``fire wall'' with
respect to such broker-dealers regarding access to information
concerning the composition and/or changes to the Fund's portfolio,
and will continue to be in compliance with Commentary .06 to NYSE
Arca Equities Rule 8.600. In the event (a) the Adviser or any sub-
adviser becomes newly affiliated with a broker-dealer, or (b) any
new adviser or sub-adviser becomes affiliated with a broker-dealer,
it will implement a fire wall with respect to such broker-dealer
regarding access to information concerning the composition and/or
changes to the portfolio, and will be subject to procedures designed
to prevent the use and dissemination of material non-public
information regarding such portfolio.
    \6\ See Post-Effective Amendment No. 5 to Form N-1A for the
Trust, dated April 29, 2011 (File Nos. 333-160877; 811-22320)
(``Registration Statement''). In addition, the Commission has issued
an order granting certain exemptive relief to the Trust under the
Investment Company Act of 1940 (``1940 Act''). See Investment
Company Act Release No. 29164 (March 1, 2010) (File No. 812-13815
and 812-13658-01) (``Exemptive Order'').
    \7\ The Adviser represents that, for one year following
implementation of the change to the benchmark index, materials
issued by the Fund relating to Fund performance, including materials
posted on the Fund's Web site (http://www.russelletfs.com), will
reference both the current benchmark and the new benchmark index, in
accordance with Item 27(b)(7) of Form N-1A under the 1940 Act. The
Adviser represents that the benchmark index change will be
referenced on Russell's Web site, and that the quarterly fact sheet
for the Fund, available on the Fund's Web site, will reference the
current benchmark and the new benchmark index for one year.
---------------------------------------------------------------------------

    As a result of the acquisition of U.S. One, Inc. by Russell, the
Fund seeks to change its underlying benchmark to the Russell Developed
Large Cap Index (``Index'') from the Fund's current benchmark, the S&P
500 Index.\8\ The Index offers investors access to the large-cap
segment of the developed equity universe representing approximately
75.4% of the global equity market. The Index includes the largest
securities in the Russell Developed Index. As of May 31, 2010, the
Index included 2,372 securities in 25 developed countries, with a
market capitalization ranging from $238 billion to $1.3 billion; the
weighted average market capitalization of Index components was $54.7
billion; and the largest three Index securities and associated Index
weights were Exxon Mobil (1.58%); Apple Inc. (1.17%); and Chevron Corp.
(0.79%). The current benchmark, the S&P 500 Index, includes 500 leading
companies in leading industries of the U.S. economy, capturing 75%
coverage of U.S. equities. It focuses on large capitalization
securities and represents approximately 75% of the U.S. market
capitalization. A committee determines the securities included based on
a set of published guidelines. The Index includes the Russell
1000[supreg], which represents 90% of U.S. market capitalization. It
also includes an additional 1,372 securities which, as of May 31, 2010,
were listed in other developed countries. The Adviser represents that
the investment objective of the Fund has not changed, the Index more
accurately represents the investment strategy of the Fund, and the
change to the Fund's benchmark will not impact the investment objective
or

the principal investment strategies for the Fund.
---------------------------------------------------------------------------

    \8\ The change to the Fund's benchmark Index will be effective
upon filing with the Commission of an amendment to the Trust's
Registration Statement.
---------------------------------------------------------------------------

    The Adviser has represented that it believes the Index is an
appropriate broad-based benchmark index for the Fund and the Fund's
investment objective. As represented in the One Fund Release, the
Fund's investment objective is to seek long-term capital appreciation
by investing at least 80% of its total assets in exchange-traded funds
(``Underlying ETFs'') that track various securities indices comprised
of large, mid, and small capitalization companies in the United States,
Europe, and Asia, as well as other developed and emerging markets. As
stated in the One Fund Release, the Adviser intends to hold Underlying
ETFs that hold equity securities of large, mid, and small
capitalization companies in the United States, as well as other
developed countries and developing countries, and that give the Fund
exposure to most major developed and developing markets around the
world.\9\ Thus, whereas the S&P 500 Index mostly reflects U.S.-based
companies, the Index includes a broader range of issuers from both the
domestic and international markets, and such range is consistent with,
and should better reflect, the Fund's investment objective. The
Exchange further states that, except for the changes noted above, all
other representations made in the One Fund Release remain unchanged.
---------------------------------------------------------------------------

    \9\ The Adviser employs an asset allocation strategy focused on
increasing shareholder return and reducing risk through exposure to
a variety of domestic and foreign market segments. The Adviser's
asset allocation strategy pre-determines a target mix of investment
types for the Fund to achieve its investment objective and then
implements the strategy by selecting securities that best represent
each of the desired investment types. The strategy also calls for
periodic review of the Fund's holdings as markets rise and fall to
ensure that the portfolio adheres to the target mix and indicates
purchases and sales necessary to return to the target mix. The
Adviser selects Underlying ETFs based on their ability to accurately
represent the underlying stock market to which the Adviser seeks
exposure for the Fund, and seeks to construct a portfolio that will
outperform its benchmark. Additionally, the Adviser seeks to
maintain a low after-tax cost structure for the Fund and, therefore,
also evaluates ETFs based on their underlying costs. The Adviser
employs a buy and hold strategy, meaning that it buys and holds
securities for a long period of time, with minimal portfolio
turnover. The Fund, using a buy and hold strategy, seeks to achieve
its investment objective through investment in Underlying ETFs that
track certain securities indices. While the Fund intends to
primarily invest in Underlying ETFs that hold equity securities, the
Adviser may also invest in Underlying ETFs that may hold U.S. and
foreign government debt and investment grade corporate bonds.
According to the Registration Statement, the Fund does not invest in
derivatives. See One Fund Release, supra note 4.
---------------------------------------------------------------------------

III. Discussion and Commission's Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the requirements of Section 6 of the
Act and the rules and regulations thereunder applicable to a national
securities exchange.\10\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\11\ which
requires, among other things, that the Exchange's rules be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \10\ In approving this proposed rule change the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \11\ 17 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission notes that the Fund's benchmark Index will continue
to be a broad-based index of large capitalization companies. The Index
represents approximately 75.4% of the global equity market and includes
the largest securities in the Russell Developed Large Cap Index. The
Fund's investment objective continues to seek long-term capital
appreciation by investing at least 80% of its total assets in
Underlying ETFs that are listed and traded on a national securities
exchange and that track various securities indices comprised of large,
mid, and small capitalization companies in the United States, Europe,
and Asia, as well as other developed and emerging markets. The Index
includes a broad range of issuers from both the domestic and
international markets, and the Commission believes that such range is
consistent with the Fund's existing investment objective. In addition,
the Adviser represents that the investment objective of the Fund has
not changed, and the change to the Fund's benchmark will not impact the
investment objective or the principal investment strategies for the
Fund. Further, the Adviser has represented that the change to the
Fund's benchmark will not impact shareholders of the Fund. Importantly,
the Exchange states that, except for the changes noted above, all other
representations made in the One Fund Release remain unchanged and that
the Fund will continue to comply with all initial and continued listing
requirements under NYSE Arca Equities Rule 8.600. The Commission notes
that the value of the new benchmark Index will continue to be
calculated and disseminated in a manner consistent with the
representations in the One Fund Release relating to the previous
benchmark index.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-NYSEArca-2010-53) be, and it
hereby is, approved.

    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25194 Filed 9-29-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Rules and Regulations]
[Pages 87719-87720]
[FR Doc No: 2023-27842]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0962]

Safety Zone; Lower Mississippi River, Mile Markers 94 to 97 Above
Head of Passes, New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone on December 30,
2023, for the University of Texas Sugar Bowl Barge Show fireworks
display located on the navigable waters of the Lower Mississippi River
between Mile Marker (MM) 95.5 and MM 96.5. Our regulation for Safety
Zone; Lower Mississippi River, Mile Markers 94 to 97 above Head of
Passes, New Orleans, LA, identifies the regulated area for this event.
This action is necessary to provide for the safety of life on these
navigable waterways during this event. During the enforcement period,
entry into this safety zone is prohibited unless authorized by the
Captain of the Port or a designated representative.

DATES: The regulations in 33 CFR 165.845 will be enforced from 9:45
p.m. through 10:30 p.m. on December 30, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Commander William
Stewart, Sector New Orleans, U.S. Coast Guard; telephone (504) 365-
2246, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a safety zone
for the University of Texas Sugar Bowl Barge Show fireworks display
from 9:45 p.m. through 10:30 p.m. on December 30, 2023, to provide for
the safety of life on the navigable waterways during this event. Our
regulation for Safety Zone; Lower Mississippi River, mile markers 94 to
97 above Head of Passes, New

Orleans, LA, in 33 CFR 165.845(a), specifies the location of the
regulated area on the Lower Mississippi River, between MM 95.5 and MM
96.5. During the enforcement period, as reflected in 33 CFR 165.845(c),
entry into this safety zone is prohibited unless authorized by the
Captain of the Port or a designated representative.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via Marine Safety Information Bulletin and Broadcast
Notice to Mariners.

    Dated: December 13, 2023.
K.K. Denning,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2023-27842 Filed 12-18-23; 8:45 am]
BILLING CODE 9110-04-P