[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Page 69275]
[FR Doc No: 2015-28362]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0084]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated July 6, 2015, the Southeastern Pennsylvania Transportation
Authority (SEPTA) has petitioned the Federal Railroad Administration
(FRA) for a waiver of compliance from several provisions of the Federal
railroad safety regulations contained at 49 CFR part 240, Qualification
and Certification of Locomotive Engineers, and Part 242, Qualification
and Certification of Conductors. FRA assigned the petition Docket
Number FRA-2015-0084. The relief is contingent on SEPTA's
implementation of and participation in the Confidential Close Call
Reporting System (C3RS) pilot project.
    SEPTA seeks to shield reporting employees and the railroad from
mandatory punitive sanctions that would otherwise arise as provided in
49 CFR 240.117(e)(1)-(4); 240.305(a)(l)-(4) and (a)(6); 240.307;
242.403(b), (c), (e)(l)-(4), (e)(6)-(11), and (f)(l)-(2); and 242.407.
The C3RS pilot project encourages certified operating crew members to
report close calls and protect the employees and the railroad from
discipline or sanctions arising from incidents reported per the C3RS
Implementing Memorandum of Understanding.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by December 24, 2015 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice for the privacy
notice of regulations.gov.

    Issued in Washington, DC, on Monday, October 26, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-28362 Filed 11-6-15; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: December 23, 2009 (Volume 74, Number 245)]
[Proposed Rules]
[Page 68208-68214]
[DOCID:fr23de09-25]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 104, 105, 160

[USCG-2004-19963]
RIN 1625-AA93

Notification of Arrival in U.S. Ports; Certain Dangerous Cargoes

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: On December 16, 2005, the Coast Guard published an interim
rule that defined ``certain dangerous cargo residue'' (CDC residue).
After reviewing comments on the interim rule, the Coast Guard proposes
to change that definition to include certain bulk liquids and liquefied
gases in residue quantities. Based on changes to the CDC residue
definition, the Coast Guard also proposes to revise the definition of
``certain dangerous cargo.'' Additionally, the Coast Guard intends to
adopt changes made to 33 CFR part 104 and 105 by the 2005 interim rule.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before February 22,
2010 or reach the Docket Management Facility by that date. Comments
sent to the Office of Management and Budget (OMB) on collection of
information must reach OMB on or before February 22, 2010.

ADDRESSES: You may submit comments identified by docket number USCG-
2004-19963 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. For
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.
    Collection of Information Comments: If you have comments on the
collection of information discussed in section VI.D. of this notice of
proposed rulemaking (NPRM), you must also send comments to the Office
of Information and Regulatory Affairs (OIRA), Office of Management and
Budget. To ensure that your comments to OIRA are received on time, the
preferred methods are by e-mail to<EMAIL_ADDRESS>(include the docket number and ``Attention: Desk Officer for Coast
Guard, DHS'' in the subject line of the e-mail) or fax at<PHONE_NUMBER>.
An alternate, though slower, method is by U.S. mail to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW., Washington, DC 20503, ATTN: Desk Officer, U.S.
Coast Guard.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Lieutenant Sharmine Jones, Office of Vessel Activities, U.S.
Coast Guard Headquarters, telephone<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Ms. Renee V.
Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
    D. Public Meeting
II. Abbreviations

III. Background and Purpose
    A. History of This Rulemaking
    B. Parallel Rulemaking Affecting This Rulemaking
IV. Discussion of Comments on the Interim Rule
    A. CDC Residue
    B. NOAs and Port Scheduling
    C. Definition of Charterer
    D. Foreign Recreational Vessels
V. Discussion of Proposed Rule
    A. Proposed Changes to Definitions of CDC and CDC Residue
    B. Interim Rule Changes To Be Adopted
    C. Interim Rule Changes Affected by Parallel Rulemaking
VI. Regulatory Analysis
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2004-19963), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://regulations.gov, insert
``USCG-2004-19963'' in the ``Keyword'' box, and click ``Search''; then
click on the balloon shape in the ``Actions'' column. 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 they have reached the Facility, please enclose a stamped, self-
addressed postcard or envelope.
    We will consider all comments and material received during the
comment period. We may change this proposed rule based on your
comments.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
insert ``USCG-2004-19963'' in the ``Keyword'' box, and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
If you do not have access to the internet, you may view the docket
online by visiting the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

C. Privacy Act

    Anyone can search the electronic form of all comments received into
any of our 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 notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

D. Public Meeting

    We do not now plan to hold a public meeting. But, you may submit a
request for a public meeting to the docket using one of the methods
specified under ADDRESSES. In your request, explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.

II. Abbreviations

AIS Automatic identification system
CDC Certain dangerous cargo
CFR Code of Federal Regulations
COI Collection of information
CTAC Chemical Transportation Advisory Committee
DHS Department of Homeland Security
FR Federal Register
NOA Notice of arrival
NOAD AIS Vessel Requirements for Notices of Arrival and Departure, and
Automatic Identification System
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
U.S.C. United States Code

III. Background and Purpose

A. History of This Rulemaking

    The notice of arrival (NOA) is a process by which a vessel submits
required information--including data about the vessel, cargo and crew--
before the vessel arrives at a port or place in the United States. The
information contained in the NOA allows the Coast Guard to implement
appropriate safety and security measures, including security screening
and escort into port.
    In 2003, the Coast Guard became concerned about the potential
security hazards of bulk Ammonium nitrate and propylene oxide cargoes
transported on U.S. waters. After consultation with the Chemical
Transportation Advisory Committee (CTAC) and Towing Safety Advisory
Committee, the Coast Guard determined that these substances should be
considered ``certain dangerous cargoes'' (CDCs). Regulations at 33 CFR
160.204 specifically define CDCs, but, in general terms, CDCs are
substances or materials that pose an unreasonable risk to health,
safety, and property if improperly handled. Existing regulations
require most vessels carrying CDCs to submit NOAs.
    The Coast Guard published a temporary final rule on August 18,
2004, titled ``Notification of Arrival in U.S. Ports; Certain Dangerous
Cargoes; Electronic Submission'' (69 FR 51176). That temporary final
rule changed the definition of ``certain dangerous cargo (CDC)'' to
include: ammonium nitrate, in bulk; ammonium nitrate based fertilizers,
in bulk; and propylene oxide, alone or mixed with ethylene oxide, in
bulk. The temporary final rule also updated 33 CFR parts 104 and 105 on
vessel and facility security to include these new CDCs. In addition,
the temporary final rule implemented two new optional formats for
electronic submittal of NOAs.
    The Coast Guard published an interim rule on December 16, 2005,
titled ``Notification of Arrival in U.S. Ports; Certain Dangerous
Cargoes; Electronic Submission'' (70 FR 74663). That interim rule made
permanent the definition of CDC as implemented in the 2004 temporary
final rule. The interim rule also made permanent the application of
vessel security requirements at 33 CFR part 104 to barges carrying
CDCs. However, the interim rule removed the remainder of the temporary
changes made to 33 CFR parts 104 and 105 because they were no longer
necessary.
    The interim rule also added changes that had not been included in
the 2004

temporary final rule. First, the interim rule added another optional
method for electronic submittal of NOAs. Second, the interim rule
clarified that 33 CFR part 160 on NOAs does not apply to U.S.
recreational vessels under 46 U.S.C. 4301. Third, the interim rule
added a definition of ``CDC residue'' that, in effect, exempted certain
vessels carrying CDC residue from the same NOA requirements imposed on
vessels carrying CDCs. The 2005 definition of CDC residue is limited to
residue quantities of bulk ammonium nitrate or ammonium nitrate
fertilizer remaining onboard after the vessel discharges all saleable
cargo; no other cargo residues fall within the current definition of
``CDC residue.''
    In response to the 2005 interim rule, the Coast Guard received
comments from the Chemical Transportation Advisory Committee (CTAC)
suggesting the Coast Guard revise the definition of CDC residue to
include some bulk liquids and liquefied gases. The Coast Guard tasked
CTAC's Hazardous Cargoes Transportation Security Subcommittee with
reviewing the current requirement that a CDC vessel remain a CDC vessel
until the removal of all bulk liquid and liquefied gas CDC cargoes,
including residue quantities of such cargoes, from the vessel. The
Committee completed its recommendation on August 24, 2006, and
submitted it to the Coast Guard for review and consideration. The Coast
Guard concurs with CTAC and, with this NPRM, proposes to amend the
definitions of CDC and CDC residue consistent with CTAC's
recommendation.

B. Parallel Rulemaking Affecting This Rulemaking

    Concurrent with this proposal to amend the definition of CDC
residue, a parallel rulemaking effort has proposed to renumber relevant
paragraphs and change some of the provisions implemented by the 2005
interim rule. That parallel rulemaking is ``Vessel Requirements for
Notices of Arrival and Departure, and Automatic Identification System''
(NOAD AIS). The Coast Guard published an NPRM on December 16, 2008, and
the comment period closed on April 15, 2009 (73 FR 76295). Section
V.C., ``Interim Rule Changes Affected by Parallel Rulemaking,''
discusses the impact of this NOAD AIS proposal on specific provisions
implemented by the 2005 interim rule. You may read the NOAD AIS
proposal, and public comments on it, at docket USCG-2005-21869.

IV. Discussion of Comments on the Interim Rule

    The Coast Guard received two letters commenting on the 2005 interim
rule: one submitted by an advisory committee and the other submitted by
a trade association. The letter from the advisory committee addressed
several issues associated with CDC residue and NOAs. The letter from
the trade association addressed the clarification made by the interim
rule with regard to applicability of 33 CFR part 160. The Coast Guard
received no comments on the interim rule as it affected 33 CFR parts
104 and 105 or the electronic submission of NOAs.

A. CDC Residue

    One commenter sought to provide information on industry practices
relevant to vessel transport of CDCs. In particular, the commenter
described the manner in which chemical cargo residues are diluted by
washing the tanks with water or by loading another cargo over the
residue. The commenter suggested that these practices, as well as the
practice of carrying multiple cargoes on one vessel, reduce the risk of
an intentional incident involving CDC residues. The commenter suggested
the Coast Guard undertake further study of CDC residues in order to
avoid expending Coast Guard and industry resources on unnecessary
security precautions. The Coast Guard agreed with this recommendation
and tasked the Chemical Transportation Advisory Committee (CTAC) with
providing recommendations on CDC residue. The Committee's
recommendations form the basis of the Coast Guard's proposal in this
NPRM.
    The same commenter suggested that the definition of ``CDC residue''
implemented by the interim rule be renamed ``Ammonium Nitrate Residue''
to avoid implying that all CDCs carried in residue quantities satisfy
the definition. With this NPRM, the Coast Guard proposes to broaden the
definition of ``CDC residue'' to include cargo residue other than
ammonium nitrate, thereby removing the possibility of confusion.

B. NOAs and Port Scheduling

    One commenter described the difficulty of complying with NOA
requirements when vessels plan to call at multiple berths in the same
port. The commenter indicated that the minimum notice required before
transit to another berth causes delays and unnecessary ship movements,
contributing to traffic congestion in busy ports. This proposed rule is
likely to reduce the number of intra-port transits requiring NOAs
because it broadens the definition of CDC residue. However, the general
issues of port congestion and NOAs for intra-port transit are outside
the scope of the interim rule and this NPRM, neither of which addresses
the time for the submission of NOAs. We have forwarded these comments
to the appropriate program staff for further consideration and
appropriate action.
    The same commenter suggested that the Coast Guard use Vessel
Traffic Service systems and/or Automatic Identification System coverage
to track vessel movements in the port area, instead of requiring NOAs.
In this proposed rule, the Coast Guard is revising the definition of
CDC and CDC residue in its NOA regulations. Because the Coast Guard
escorts vessels carrying CDC in ports, this proposed change would allow
the Coast Guard to focus on vessels that are loaded with a CDC cargo
and free it from having to escort vessels that are only transporting
CDC residue. This proposed rule would also relieve some vessels that do
not operate in VTS areas from having to submit NOAs. This commenter's
recommendation goes beyond the scope of this rulemaking so we are
forwarding it to the appropriate program staff for consideration in the
NOAD AIS rulemaking.

C. Definition of Charterer

    One commenter suggested that requiring NOAs to include the identity
of the vessel charterer provides minimal value to the Coast Guard. In
addition, this commenter indicated that individual companies submitting
NOAs identify the vessel charterer differently because the definition
of ``charterer'' is confusing. Regulations at 33 CFR 160.204 define the
term charterer to mean ``the person or organization that contracts for
the majority of the carrying capacity of a ship for the transportation
of cargo to a stated port for a specified period. This includes `time
charterers' and `voyage charterers'.'' However, the use of the
information collected in the NOA is outside the narrow scope of the
interim rule and this NPRM. We have forwarded these comments to the
appropriate program staff for further consideration and appropriate
action.

D. Foreign Recreational Vessels

    One commenter expressed concern that the term ``foreign
recreational vessels'' could create confusion between foreign-made
vessels and foreign-owned vessels. Specifically, the commenter
recommended inserting a reference to the definition of ``vessel of the
United States'' found in 46 App. U.S.C. 1903(b).

The Coast Guard agrees that the phrase ``U.S. recreational vessels
under 46 U.S.C. 4301 et seq.'' could create some confusion, as it does
not directly refer to definitions found in Title 46 of the United
States Code. As discussed below, the provision that concerns this
commenter is addressed in the parallel NOAD AIS rulemaking proceeding.
    As part of the separate NOAD AIS rulemaking mentioned earlier in
this preamble, the Coast Guard has proposed to delete the provision
that is the subject of the comment, revise the remaining language on
applicability of 33 CFR part 160, and add a definition of ``foreign
vessel'' to Part 160. The proposed revisions should clarify the issues
identified by the commenter concerned about Sec.  160.202(b).
Interested parties may review the NOAD AIS proposal at docket USCG-
2005-21869.

V. Discussion of Proposed Rule

A. Proposed Changes to Definitions of CDC and CDC Residue

    The Coast Guard proposes to amend the definition of CDC residue to
include certain bulk liquids and liquefied gases that remain onboard in
a cargo system after discharge and are not accessible through normal
transfer procedures. A vessel carrying only CDC residue may qualify for
an NOA exemption for vessels not carrying CDC, provided it meets
criteria in Sec.  160.203(b). Changing the definition of CDC residue
will allow the Coast Guard to better allocate resources to vessels that
are carrying CDCs and not just CDC residue.
    In formulating this proposal, the Coast Guard considered aspects of
the transportation industry and chemical properties to decide which
chemicals to include in the definition. These aspects included: Real-
life workings of vessels in handling residues; methods of pumping
material; the quantity of cargo remaining onboard after discharge,
including stripping, cleaning tanks, etc.; the relative hazard of CDCs;
physical properties of the chemicals; vapor pressures of the chemicals;
toxicity of the chemicals; and exposure guidelines for the chemicals.
    The Coast Guard believes that expanding the definition of CDC
residue is appropriate for several reasons. First, discharging a
typical chemical cargo leaves a minimal amount of cargo in the tank
that is not accessible using the normal pumping system. Second,
preparing the tank for a new cargo effectively removes the potential
hazard of the previous cargo due to dilution or removal of the
potential hazard. Third, with specific respect to liquefied gases, gas
tankers carry residue at a pressure well below its vapor pressure,
which mitigates the hazard.
    The Coast Guard also proposes that a few bulk liquid and liquefied
gas cargoes should remain CDCs even when carried in residue quantities.
We base this proposal primarily on the relative hazard created by the
vapor pressure of the cargo and its potential impact to health and
safety. Therefore, the Coast Guard proposes to amend the definition of
CDC residue to specify that the following cargoes remain CDCs at all
times, even when only residue quantities remain onboard: anhydrous
ammonia, chlorine, ethane, ethylene oxide, methane (LNG), methyl
bromide, sulfur dioxide, and vinyl chloride. Under this proposal,
vessels carrying residue quantities of these cargoes will remain CDC
vessels.

B. Interim Rule Changes To Be Adopted

    The 2005 interim rule made changes to 33 CFR parts 104 and 105
dealing with vessel security regulations for CDC vessels. In
particular, the interim rule adopted the change, first made in the 2004
temporary final rule, specifying that 33 CFR part 104 applies to barges
carrying CDCs in bulk and engaged on international voyages.
Additionally, the 2005 interim rule removed all other changes made to
parts 104 and 105 by the 2004 temporary final rule, because those
paragraphs were no longer necessary. The Coast Guard proposes to adopt
these part 104 and 105 changes introduced by the interim rule as final.

C. Interim Rule Changes Affected by Parallel Rulemaking

    The 2005 interim rule also updated electronic submission options by
adding the eNOAD system as an optional method for electronically
submitting NOAs under 33 CFR part 160. However, an NPRM published in
the parallel NOAD AIS rulemaking proposes to revise Sec.  160.210 to
require that all NOAs be submitted electronically.
    Separately, the 2005 interim rule added a new paragraph, Sec.
160.202(b), clarifying that the NOA provisions in Part 160 do not apply
to U.S. recreational vessels. The NOAD AIS rulemaking proposes to
remove Sec.  160.202(b), renumber Sec.  160.202 as Sec.  160.203, and
revise the new Sec.  160.203(a) to read: ``This subpart applies to U.S.
vessels in commercial service and all foreign vessels that are bound
for or departing from ports or places of the United States.''
Similarly, the NOAD AIS proposal would renumber Sec.  160.204 as Sec.
160.202, and add definitions of ``commercial service'' and ``foreign
vessel.''
    In light of the NOAD AIS proposal to remove or revise these two
sections affected by the 2005 interim rule, the Coast Guard does not
expect to address either section in the final rule to follow this NPRM.
Interested parties may review the relevant sections in the NOAD AIS
docket at USCG-2005-21869.

VI. Regulatory Analysis

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we present our
analysis based on 13 of these statutes or executive orders.

A. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review.
OMB has not reviewed it under that Order.
    As discussed in the ``Background and Purpose'' section of this
proposed rule, the Coast Guard published an interim rule in 2005 that
changed the definition of certain dangerous cargo (CDC) to include
ammonium nitrate, in bulk; ammonium nitrate based fertilizers, in bulk;
and propylene oxide, alone or mixed with ethylene oxide, in bulk. In
the regulatory analysis for the interim rule, the Coast Guard presented
the costs and impacts associated with changing the definition of CDC
(70 FR 74663).
    After publication of the interim rule, the Coast Guard received
comments and recommendations from the Chemical Transportation Advisory
Committee (CTAC). Based on these recommendations, the Coast Guard
proposes to change the definition of CDC so that residue quantities of
some chemicals are not CDC. CTAC defined residue as the cargo that
remains onboard in a cargo system after discharge that is not
accessible through normal transfer procedures. Currently, vessel
operators affected by the interim rule are required to submit a notice
of arrival (NOA) when transporting CDC, regardless of quantity
(including residue amounts). If the Coast Guard adopts this change,
some vessel operators would no longer be required to submit NOAs when
transporting residue quantities of CDCs. Some chemicals will continue
to be considered CDCs in residue amounts (see the ``Discussion of
Proposed Rule'' section for more details). Vessel owners carrying these
chemicals will continue submitting NOAs when transporting these
chemicals in residue amounts, which is the current practice under the
interim rule.
    Due to the proposed change in the definition of CDC, we expect
there

would be a reduction in the cost and reporting burden for vessel owners
who transport CDCs in residue amounts. The Coast Guard does not have
precise estimates of how many vessel trips or vessel owners will no
longer be subject to the NOA requirement. Under current requirements,
there is no distinction made for shipments of CDC in residue status.
    Based on data from the Coast Guard Ship Arrival Notification System
(SANS), we estimate there are on average 2,800 vessels currently
carrying CDC that make approximately 25,000 port arrivals a year. Under
the current interim rule baseline, each of these vessel arrivals
involving CDCs in any amount would require an NOA. Under the proposed
rule, some of these vessel arrivals would no longer require an NOA if
the vessel is carrying certain CDCs in residue quantity. Based on
information from the Coast Guard Office of Vessel Activities, we
estimate that there will be at least a five-percent annual reduction in
the number of NOA submittals as a result of this proposed rule. Changes
in vessel operations and the demand for marine transportation of bulk
CDC shipments may affect these estimates.
    Based on data in the existing collection of information ``Advance
Notice of Vessel Arrival,'' OMB Control Number 1625-0100, we estimate
the NOA preparation time to be about 30 minutes (0.5 hours). We
estimate the cost for an NOA submission to be about $17.50 ((0.5 hours
x $31 labor rate/hour) + $2 transmittal fee).\1\ Therefore, we consider
a five-percent annual reduction in NOA submissions to be equivalent to
a $22,000 decrease in cost burden for vessel operators that transport
certain CDCs in residue status.\2\ This would also result in a
reduction in the NOA information the Coast Guard would need to process.
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    \1\ Sources for time, labor rate and transmittal fee estimates:
(1) Collection of Information, OMB Control Number 1625-0100,
``Advance Notice of Vessel Arrival,'' Supplementary Document ``1625-
0100 eNOAD NPRM R1,'' January 14, 2009; and (2) Notice of Proposed
Rulemaking, ``Vessel Requirements for Notices of Arrival and
Departure, and Automatic Identification System'' docket number USCG-
2005-21869.
    \2\ The figure $22,000 is rounded from $21,875 = $17.50 NOA cost
x 25,000 arrivals x 0.05 [the 5% reduction in NOA].
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    The Coast Guard carefully considered chemical properties and
aspects of the transportation industry in determining which chemicals
to include or exclude from the definition of CDC residue. The Coast
Guard excluded chemicals that may pose an unreasonable risk in residue
quantities from the proposed changes to the definition of CDC residue.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not governmental
jurisdictions with populations fewer than 50,000 people.
    This proposed rule would not increase the NOA reporting costs to
vessel operators shipping CDC. This rulemaking would reduce the burden
to vessel operators shipping residue quantities of certain CDCs.
Therefore, the Coast Guard certifies that under 5 U.S.C. 605(b) this
proposed rule would not have a significant economic impact on a
substantial number of small entities. If you think that your business,
organization, or governmental jurisdiction qualifies as a small entity
and that this rulemaking would have a significant economic impact on
it, please submit a comment to the Docket Management Facility at the
address under ADDRESSES. In your comment, explain why you think it
qualifies and how and to what degree this rulemaking would economically
affect it.

C. Assistance for Small Entities

    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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please consult Lieutenant
Sharmine Jones, Office of Vessel Activities (CG-5432), Coast Guard,
telephone<PHONE_NUMBER>. The Coast Guard will not retaliate against
small entities that question or complain about this proposed rule or
any policy or action of the Coast Guard.
    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).

D. Collection of Information

    This proposed rule does not require a new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). It
would modify an existing collection under OMB Control Number 1625-0100,
Advance Notice of Vessel Arrival.
    As defined in 5 CFR 1320.3(c), ``collection of information''
comprises reporting, recordkeeping, monitoring, posting, labeling, and
other, similar actions. The title and description of the information
collection, a description of those who must collect the information,
and an estimate of the total annual burden follow. The estimate covers
the time for reviewing instructions, searching existing sources of
data, gathering and maintaining the data needed, and completing and
reviewing the collection.
    Due to the proposed change in the definition of CDC, we expect that
this rulemaking would reduce the annual burden for vessel operators who
transport certain CDCs. Regulations would no longer require vessel
operators to submit NOAs when transporting residue quantities of
certain CDCs. This proposed rule would result in a reduction of the
total number of annual respondents and responses in the existing
collection under OMB Control Number 1625-0100. The following is a
summary of the changes to the existing collection as a result of this
proposed rule and updated ship arrival data. The Coast Guard based most
of the information on estimates discussed in the ``Regulatory Planning
and Review'' section and data from the Coast Guard Ship Arrival
Notification System (SANS).
    Title: Advance Notice of Vessel Arrival.
    OMB Control Number: 1625-0100.
    Summary of the Collection of Information: The Coast Guard requires
pre-arrival notices from certain vessels entering a port or place in
the United States. These vessels include those carrying a CDC as
defined in 33 CFR 160.204. This proposed rule would change the
definition of CDC so that residue quantities of some chemicals would no
longer be considered CDC. As a result, the Coast Guard would no longer
require vessel operators to submit NOAs when transporting residue
quantities of certain CDCs.
    Need for Information: To ensure port safety and security and to
ensure the uninterrupted flow of commerce.

    Proposed Use of Information: The Coast Guard would use the
information to enhance maritime domain awareness.
    Description of the Respondents: Respondents are the owners, agents,
masters, operators, or persons in charge of a vessel that carries a CDC
and arrives at a port or place in the United States.
    Number of Respondents: The total number of respondents for the
collection of information is 31,594 per year. The number of these
respondents or vessels (the subset of the total number of vessels)
affected by this rulemaking is 2,800 per year.
    Frequency of Response: The frequency or number of responses
associated with the collection of information is 170,866 per year. The
number of these responses associated with CDC transits affected by this
rulemaking is about 25,000 per year. This rulemaking would decrease
that number of responses by about 5 percent or 1,250 per year [25,000 X
0.05 (the 5% reduction in NOA)].
    Burden of Response: The burden of response associated with the
collection of information is approximately 30 minutes or 0.5 hours per
response. This rulemaking would not change the burden of response. It
would reduce the number of responses.
    Estimate of Total Annual Burden: The total annual burden for the
collection of information is 163,994 hours per year for all NOA
respondents. We estimate this proposed rule would reduce the total
annual burden by 625 hours per year.\3\
---------------------------------------------------------------------------

    \3\ 625 hours per year reduction = 1,250 less NOA responses per
year x 0.5 hours per NOA.
---------------------------------------------------------------------------

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted a copy of this proposed rule to the Office
of Management and Budget (OMB) for its review of the collection of
information. We ask for public comment on the collection of information
to help us determine how useful the information is; whether it can help
us perform our functions better; whether it is readily available
elsewhere; how accurate our estimate of the burden of collection is;
how valid our methods for determining burden are; how we can improve
the quality, usefulness, and clarity of the information; and how we can
minimize the burden of collection. If you submit comments on the
collection of information, submit them both to OMB and to the Docket
Management Facility where indicated under ADDRESSES, by the date under
DATES. You need not respond to a collection of information unless it
displays a currently valid control number from OMB.

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

F. 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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

G. Taking of Private Property

    This proposed rule would not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

H. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

J. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

K. Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

M. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f) and have
made a preliminary determination that this action is one of a category
of actions which does not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under the ``Public
Participation and Request for Comments'' section of this preamble. This
rule involves editorial or procedural regulations, such as those
updating addresses or establishing applications procedures and
regulations concerning manning, documentation, admeasurement,
inspection, and

equipping of vessels. We seek any comments or information that may lead
to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects

33 CFR Part 104

    Maritime security, Reporting and recordkeeping requirements,
Security measures, and Vessels.

33 CFR Part 105

    Maritime security, Reporting and recordkeeping requirements, and
Security measures.

33 CFR Part 160

    Administrative practice and procedure, Harbors, Hazardous materials
transportation, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Vessels, and Waterways.
    For the reasons discussed in the preamble, the Coast Guard proposes
to adopt the amendments to 33 CFR parts 104 and 105, introduced by the
interim rule published at 70 FR 74669 on December 16, 2005, as final,
and to amend 33 CFR part 160 as follows:

PART 160--PORTS AND WATERWAYS SAFETY-GENERAL

    1. The authority citation for part 160 continues to read as
follows:

    Authority:  33 U.S.C. 1223, 1231; 46 U.S.C. Chapter 701;
Department of Homeland Security Delegation No. 0170.1. Subpart D is
also issued under the authority of 33 U.S.C. 1225 and 46 U.S.C.
3715.

    2. In Sec.  160.204, revise paragraphs (7) through (9) of the
definition for ``Certain dangerous cargo (CDC)'' and the entire
definition of ``Certain dangerous cargo residue (CDC residue)'' to read
as follows:

Sec.  160.204  Definitions.

* * * * *
    Certain dangerous cargo (CDC) includes any of the following:
* * * * *
    (7) All bulk liquefied gas cargo carried under 46 CFR 151.50-31 or
listed in 46 CFR 154.7 that is flammable and/or toxic and that is not
carried as certain dangerous cargo residue (CDC residue).
    (8) The following bulk liquids except when carried as CDC residue:
    (i) Acetone cyanohydrin;
    (ii) Allyl alcohol;
    (iii) Chlorosulfonic acid;
    (iv) Crotonaldehyde;
    (v) Ethylene chlorohydrin;
    (vi) Ethylene dibromide;
    (vii) Methacrylonitrile;
    (viii) Oleum (fuming sulfuric acid); and
    (ix) Propylene oxide, alone or mixed with ethylene oxide.
    (9) The following bulk solids:
    (i) Ammonium nitrate listed as a Division 5.1 (oxidizing) material
in 49 CFR 172.101 except when carried as CDC residue; and
    (ii) Ammonium nitrate based fertilizer listed as a Division 5.1
(oxidizing) material in 49 CFR 172.101 except when carried as CDC
residue.
    Certain dangerous cargo residue (CDC residue) includes any of the
following:
    (1) Ammonium nitrate in bulk or ammonium nitrate based fertilizer
in bulk remaining after all saleable cargo is discharged, not exceeding
1,000 pounds in total and not individually accumulated in quantities
exceeding two cubic feet.
    (2) For bulk liquids and liquefied gases, the cargo that remains
onboard in a cargo system after discharge that is not accessible
through normal transfer procedures, with the exception of the following
bulk liquefied gas cargoes carried under 46 CFR 151.50-31 or listed in
46 CFR 154.7:
    (i) Ammonia, anhydrous;
    (ii) Chlorine;
    (iii) Ethane;
    (iv) Ethylene oxide;
    (v) Methane (LNG);
    (vi) Methyl bromide;
    (vii) Sulfur dioxide; and
    (viii) Vinyl chloride.
* * * * *

    Dated: December 15, 2009.
Kevin S. Cook,
Rear Admiral, U.S. Coast Guard, Director of Prevention Policy.
[FR Doc. E9-30347 Filed 12-22-09; 8:45 am]

BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Proposed Rules]
[Pages 1015-1016]
[FR Doc No: 2019-00656]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2016-0168; FRL-9988-29-Region 1]

Air Plan Approval; Connecticut; Motor Vehicle Inspection and
Maintenance Program Certification

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the motor vehicle emissions inspection and maintenance (I/M)
program certifications contained in State Implementation Plan (SIP)
revisions submitted by the State of Connecticut relating to the 2008 8-
hour ozone National Ambient Air Quality Standards (NAAQS). The SIP
revisions pertain to the Greater Connecticut and the Connecticut
portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT
moderate ozone nonattainment areas. The intended effect of this action
is to propose approval of Connecticut's motor vehicle emissions I/M
program certifications. This action is being taken under the Clean Air
Act (CAA).

DATES: Written comments must be received on or before March 4, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2016-0168 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov, For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets. Publicly
available docket materials are available at https://www.regulations.gov
or at the U.S. Environmental Protection Agency, EPA Region 1 Regional
Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5
Post Office Square--Suite 100, Boston, MA. EPA requests that if at all
possible, you contact the contact listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Elizabeth Hubbard, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA Region 1, 5
Post Office Square--Suite 100 (Mail Code: OEP05-2), Boston, MA 02109-
3912;<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Description of State's I/M Program Certifications
III. Evaluation of State's SIP-Approved I/M Program
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On January 17, 2017, the Connecticut Department of Energy and
Environmental Protection (DEEP) submitted a SIP revision regarding the
2008 ozone NAAQS for the Greater Connecticut moderate nonattainment
area. On August 8, 2017, Connecticut DEEP submitted a SIP revision for
the State's portion of the New York-Northern New Jersey-Long Island
(NY-NJ-CT) moderate nonattainment area for the 2008 ozone NAAQS. On
October 1, 2018, EPA published a final rulemaking (See 83 FR 49297)
approving several portions of the January 17, 2017 and August 8, 2017
SIP submittals; the final rule approved reasonable further progress
(RFP) demonstrations, motor vehicle emissions budgets (MVEBs),
reasonably available control measures (RACM) analyses, and contingency
measures for the Greater Connecticut and the Connecticut portion of the
NY-NJ-CT moderate ozone nonattainment areas. In this proposed
rulemaking action, we are proposing to approve submittals for the motor
vehicle emissions inspection and maintenance (I/M) program
certifications for the 2008 ozone NAAQS for both the Greater
Connecticut and the Connecticut portion of the NY-NJ-CT moderate
nonattainment areas. Although Connecticut's January 17, 2017 and August
8, 2017 submittals also included attainment demonstrations for the 2008
ozone standard, we are not addressing those submittals in this proposed
rulemaking. Additional background information can be found in our
October 1, 2018 final rule (83 FR 49297), the final rule's associated
proposed rulemaking on August 3, 2018 (83 FR 38104), and at https://www.regulations.gov within the Docket ID No. EPA-R01-OAR-2016-0168.

II. Description of State's I/M Program Certifications

    Under the 2008 ozone NAAQS requirements, Connecticut is required to
implement a basic I/M program for light-duty motor vehicles. However,
due to more stringent nonattainment designations under previous NAAQS
and Connecticut's inclusion as part of the Ozone Transport Region
(OTR), Connecticut implements an enhanced I/M program. The enhanced I/M
program tests gasoline-fueled and diesel-fueled motor vehicles through
10,000 pounds

gross vehicle weight rating (GVWR), requires onboard diagnostic testing
on Model Year (MY) 1996 and newer vehicles, and requires more
comprehensive tailpipe testing on MY 1995 and older vehicles. The
enhanced I/M program also implements an Emissions Control Device
Inspection through visual inspection for the presence of catalytic
converter(s) and other major emissions control equipment.

III. Evaluation of State's SIP-Approved I/M Program

    Connecticut's I/M program was first approved into the SIP on May
21, 1984 (49 FR 10542) and has been modified several times to
accommodate the CAA requirements and technological advancements such as
on-board diagnostic testing. As part of the OTR, Connecticut is
required to implement an enhanced I/M program in specific areas per CAA
184(b)(1). Connecticut exceeds federal requirements by requiring the
enhanced I/M program statewide. EPA approved revisions to Connecticut's
I/M program into the SIP in 2008 and 2015 (see 73 FR 74019 and 80 FR
13768 respectively). We find that Connecticut's I/M program
certifications further strengthen the SIP and meet federal
requirements.

IV. Proposed Action

    We are proposing to approve the motor vehicle emissions I/M program
certifications included in the attainment demonstrations submitted by
the State of Connecticut for the 2008 ozone NAAQS for the Greater
Connecticut and the Connecticut portion of the New York-Northern New
Jersey-Long Island, NY-NJ-CT moderate nonattainment areas.
    EPA is soliciting public comments on the issues discussed in this
notice or on other relevant matters. These comments will be considered
before taking final action. Interested parties may participate in the
Federal rulemaking procedure by submitting written comments to this
proposed rulemaking by following the instructions listed in the
ADDRESSES section of this Federal Register.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 21, 2018.
Alexandra Dunn,
Regional Administrator, EPA Region 1.
[FR Doc. 2019-00656 Filed 1-31-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 107 (Wednesday, June 3, 2020)]
[Notices]
[Page 34191]
[FR Doc No: 2020-11947]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR20-62-000.
    Applicants: Black Hills Wyoming Gas, LLC.
    Description: Tariff filing per 284.123(b),(e)/: Black Hills Wyoming
Gas, LLC SOC Baseline Filing to be effective 5/12/2020.
    Filed Date: 5/26/2020.
    Accession Number:<PHONE_NUMBER>58.
    Comments/Protests Due: 5 p.m. ET 6/16/2020.

    Docket Number: PR20-63-000.
    Applicants: Southwest Gas Corporation.
    Description: Tariff filing per 284.224/.123: Application for
Blanket Certificate to be effective 5/26/2020.
    Filed Date: 5/27/2020.
    Accession Number:<PHONE_NUMBER>96.
    Comments/Protests Due: 5 p.m. ET 6/17/2020.

    Docket Numbers: RP20-885-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Keyspan to
Castleton 802264 to be effective 6/1/2020.
    Filed Date: 5/27/20.
    Accession Number: 20200527-5026.
    Comments Due: 5 p.m. ET 6/8/20.
    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 date(s). 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: May 28, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-11947 Filed 6-2-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Notices]
[Page 82473]
[FR Doc No: 2020-27933]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-630-000]

325MK 8ME LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
325MK 8ME LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 4, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: December 14, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-27933 Filed 12-17-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Page 60161]
[FR Doc No: 2012-24247]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, October
4, 2012 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
October 4, 2012 will be:

    Institution and settlement of injunctive actions; institution
and settlement of administrative proceedings; and other matters
relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated:September 27, 2012.
Elizabeth M. Murphy,
 Secretary.
[FR Doc. 2012-24247 Filed 9-28-12; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Proposed Rules]
[Pages 18406-18407]
[FR Doc No: 2017-07781]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0185; Airspace Docket No. 17-ASW-6]

Proposed Amendment of Class E Airspace for the Following Texas
Towns; Pampa, TX, and Seminole, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Perry Lefors Field, Pampa, TX
and Gaines County Airport, Seminole, TX. Decommissioning of non-
directional radio beacons (NDB), cancellation of NDB approaches, and
implementation of area navigation (RNAV) procedures have made this
action necessary for the safe management of instrument flight rules
(IFR) operations at the above airports.

DATES: Comments must be received on or before June 5, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone
(202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No.
FAA-2017-0185; Airspace Docket No. 17-ASW-6, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays. The Docket Office (telephone 1-800-
647-5527), is on the ground floor of the building at the above address.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Ron Laster, Federal Aviation
Administration, Contract Support, Operations Support Group, Central
Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone
(817) 222-5879.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would modify Class E airspace extending upward from 700 feet
above the surface area at Perry Lefors Field, Pampa, TX and Gaines
County Airport, Seminole, TX.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0185/
Airspace Docket No. 17-ASW-6.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at Perry Lefors Field, Pampa,
TX. Specifically, this action would remove the segment 3 miles each
side of the 354[deg] bearing from the Pampa NDB extending from the 7.3-
mile radius to 10.1 miles north of the airport and would reduce the
Class E airspace extending upward from 700 feet above the surface at
the airport from a 7.3-mile radius to a 6.4-mile radius. This action
also proposes to modify Class E airspace extending upward from 700 feet
above the surface at Gaines County Airport, Seminole, TX by removing
the segment 2.5 miles each side of the 189[deg] bearing from the Gaines
CO NDB extending from the 6.7-mile radius to 7.7 miles south of the
airport. Airspace reconfiguration is necessary due to the
decommissioning of non-directional radio beacons (NDB), cancellation of
NDB approaches, and implementation of area navigation (RNAV) procedures
at the above airports. Controlled airspace is necessary for the safety
and management of the standard instrument approach procedures for IFR
operations at the airports.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2015, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Pampa, TX [Amended]

Pampa, Perry Lefors Field, TX
    (Lat. 35[deg]36'47'' N., long. 100[deg]59'47'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Perry Lefors Field.
* * * * *

ASW TX E5 Seminole, TX [Amended]

Seminole, Gaines County Airport, TX
    (Lat. 32[deg]40'31'' N., long. 102[deg]39'10'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of Gaines County Airport.

    Issued in Fort Worth, Texas, on April 10, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, Central Service Center.
[FR Doc. 2017-07781 Filed 4-18-17; 8:45 am]
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[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Notices]
[Pages 65409-65410]
[FR Doc No: 2020-22877]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1261]

Technical Considerations for Non-Clinical Assessment of Medical
Devices Containing Nitinol; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Technical
Considerations for Non-Clinical Assessment of Medical Devices
containing Nitinol.'' The Agency has developed this guidance to provide
FDA's current thinking on technical considerations specific to devices
using nitinol due to the unique properties of nitinol. This guidance
document is intended to provide clarity and consistency in recommended
non-clinical assessments across a variety of medical devices that
contain nitinol.

DATES: The announcement of the guidance is published in the Federal
Register on October 15, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1261 for ``Technical Considerations for Non-Clinical
Assessment of Medical Devices containing Nitinol.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Technical Considerations for Non-Clinical Assessment of Medical
Devices containing Nitinol'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Matthew Di Prima, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 2124, Silver Spring, MD 20993-0002, 301-
796-2507.

SUPPLEMENTARY INFORMATION:

I. Background

    The use of nitinol in medical devices began over three decades ago
in product areas such as orthodontic archwires, cardiovascular
guidewires, and surgical instruments. Its use has increased over the
past two decades into different device areas such as orthopaedic
fracture fixation, coronary stents, and transcatheter heart valves.
With an increasing trend to treat patients using minimally invasive
procedures, nitinol has become a popular choice of material due to its
ability to return to its original shape after being mechanically
deformed or after heat is applied. Given

the complex thermomechanical behavior of nitinol, there are unique
considerations when assessing the safety and performance of nitinol
devices.
    The Agency has developed this guidance to provide FDA's current
thinking on technical considerations specific to devices using nitinol.
These recommendations are intended to be general and apply to medical
devices that have at least one patient contacting component comprised
of nitinol. The following technical areas are covered by this guidance:
general information, mechanical testing, corrosion, biocompatibility,
and labeling of nitinol devices.
    A notice of availability of the draft guidance appeared in the
Federal Register of April 19, 2019 (84 FR 16516). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including minor technical clarifications.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on technical considerations for non-clinical
assessment of medical devices containing nitinol. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Technical Considerations for Non-Clinical
Assessment of Medical Devices containing Nitinol'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 17013 and the complete
guidance title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB Control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)``.
``FDA and Industry Procedures    513(g) Request for            0910-0705
 for Section 513(g) Requests      Information.
 for Information under the
 Federal Food, Drug, and
 Cosmetic Act``.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff``.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing
                                  Practice; Quality
                                  System Regulation.
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    Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22877 Filed 10-14-20; 8:45 am]
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