implemented to prevent exposure, where feasible.
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a) through (e)(concentration set at 1.0 percent), (f),
(g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v),
(g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii),
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use is any use other
than as a stabilizer in polyvinyl chloride (PVC) at a concentration of
no greater than 2 percent.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=0.5).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
23. Add Sec.  721.10785 to subpart E to read as follows:

Sec.  721.10785  Mixed methyltin mercaptoester sulfides (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
methyltin mercaptoester sulfides (PMN P-14-231) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the PMN substance after it has been completely reacted
(cured) or permanently entrained into a solid polyvinyl chloride
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iv), (a)(3), (b)(concentration set at
1.0 percent), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63 (a)(1), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible.
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a) through (e)(concentration set at 1.0 percent), (f),
(g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v),
(g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii),
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use is any use other
than as a stabilizer in polyvinyl chloride at a concentration of no
greater than 2 percent.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=0.5).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
24. Add Sec.  721.10786 to subpart E to read as follows:

Sec.  721.10786  Trisubsituted ethoxylated carbomonocycle (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trisubsituted ethoxylated carbomonocycle (PMN P-14-234) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=24).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
25. Add Sec.  721.10787 to subpart E to read as follows:

Sec.  721.10787  Multi-functional novolac type epoxy resin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
functional novolac type epoxy resin (PMN P-14-270) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
26. Add Sec.  721.10788 to subpart E to read as follows:

Sec.  721.10788  Alkanedioic acids, polymer with substituted
propanediol, alkanediols, and polyethylene glycol and MDI (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acids, polymer with substituted propanediol, alkanediols,
and polyethylene glycol and MDI (PMN P-14-357) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational

Safety and Health (NIOSH)-certified respirators with an Assigned
Protection Factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
    (A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
    (B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
    (C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(o) and (y)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2014-24916 Filed 10-24-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21782-21783]
[FR Doc No: 2012-8697]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0315]

International Conference on Harmonisation; Draft Guidance for
Industry on E2C(R2) Periodic Benefit-Risk Evaluation Report;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``E2C(R2)
Periodic Benefit-Risk Evaluation Report.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance updates and
combines two ICH guidances, ``E2C Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and
``Addendum to E2C Clinical Safety Data Management: Periodic Safety
Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The
draft guidance describes the format, content, and timing of a periodic
benefit-risk evaluation report (PBRER) for an approved drug or
biologic. The harmonized PBRER is intended to promote a consistent
approach to periodic postmarket safety reporting among the ICH regions
and to enhance efficiency by reducing the number of reports generated
for submission to the regulatory authorities.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 11, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the draft guidance: Andrea
Feight, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4494, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>. Regarding the ICH: Michelle Limoli, Office of
International Programs, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 3506, Silver Spring, MD 20993-0002, 301-
796-8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory Agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug

Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of May 19, 1997 (62 FR 27470), FDA
published a notice announcing the availability of the E2C guidance. In
the Federal Register of February 5, 2004 (69 FR 5551), FDA also
published the addendum to the E2C guidance to provide needed
clarification and additional guidance. Since that time, the
pharmacovigilance environment has evolved, prompting reassessment of
the role of the periodic safety update report in the spectrum of safety
documents submitted to regulatory authorities. This reassessment
highlighted several factors that led to consensus for revising the E2C
guidance and the addendum to the E2C guidance to enhance their
usefulness in light of advances in the field. There has been
significant progress in the technology and science of
pharmacovigilance, including electronic submission of individual case
safety reports to regulatory authorities, automated data mining
techniques, more attention to benefit-risk evaluation, greater emphasis
on proactive and documented risk management planning, and increasing
recognition that meaningful evaluation of important new risk
information should be undertaken in the context of a medicinal
product's benefits.
    In January 2012, the ICH Steering Committee agreed that a draft
guidance entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report''
should be made available for public comment. The draft guidance is the
product of the E2C(R2) Expert Working Group of the ICH. Comments about
this draft will be considered by FDA and the E2C(R2) Expert Working
Group.
    The draft guidance describes the format, content, and timing of a
PBRER for an approved drug or biologic. The PBRER will serve as a
common standard for periodic reporting on approved drugs or biologics
among the ICH regions. Once this guidance is finalized, applicants can
submit a waiver request for submission of the PBRER in the United
States in place of a periodic adverse drug experience report for a new
drug application, for an abbreviated new drug application, or for a
biologics license application. The harmonized PBRER is intended to
promote a consistent approach to periodic postmarket safety reporting
among the ICH regions and to enhance efficiency by reducing the number
of reports generated for submission to the regulatory authorities.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
In accordance with the PRA, before publication of the final guidance
document, FDA intends to solicit public comment and obtain OMB approval
for any information collections recommended in this guidance that are
new or that would represent material modifications to previously
approved collections of information found in FDA regulations.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: April 6, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8697 Filed 4-10-12; 8:45 am]
BILLING CODE 4160-01-P


MEMORANDUM

Date:		June 6, 2013

Subject:	Report of May 31, 2013 Site Visit to Tradebe, East Chicago, IN

From:		Tanya Parise, EC/R Incorporated

To:		Mary Tom Kissell, U.S. Environmental Protection Agency

      This memo summarizes the site visit to the Tradebe facility in East Chicago, IN, which was conducted on May 31, 2013.  The purposes of this visit were to:

          * Enhance understanding of current processes and emission controls for the off-site waste and recovery operations (OSWRO) at the facility.
          * Gain an understanding of the other applicable Clean Air Act regulations for the facility, including 40 CFR 264, 265, 279 and 40 CFR Parts 60, 61 and 63.
          * Clarify any questions the U.S. EPA has regarding the response received from the recent information collection request for this facility.

	The participants in the site visit included the following:

      Tradebe Environmental Services, LLC
      Tita LaGrimas  -  Executive VP of Regulatory Affairs
      Robert Vaughn  -  Environmental Compliance Manager

      US EPA
      Mary Tom Kissell

      EC/R Incorporated
      Lesley Stobert
      Tanya Parise

This memo includes a brief overview of this project, an overview of the Tradebe facility, and is followed by a description of the specific information gathered during the visit.

BACKGROUND

      Section 112 of the Clean Air Act (CAA) establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAP) from stationary sources. In the first stage, CAA section 112(d) requires us to promulgate technology-based national emission standards for each major source category listed under section 112(c).  These technology-based standards are often referred to as maximum achievable control technology, or MACT, standards.  The National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Off- Site Waste and Recovery Operations were promulgated on July 1, 1996 (61 FR 34140), and codified at 40 CFR part 63, subpart DD. The final rule was amended on July 20, 1999 (64 FR 38950).

      In the second stage of the regulatory process, the EPA is then required under CAA section 112(d)(6) to review these technology-based standards and revise them "as necessary (taking into account developments in practices, processes, and control technologies)" no less frequently than every eight years. In addition, within 8 years after promulgation of the MACT standards, CAA section 112(f)(2) requires the EPA to promulgate standards, if required, to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
This second stage in standard setting is referred to as the residual risk and technology review (RTR) for the standards.

      The EPA is in the process of conducting the RTR for the OSWRO MACT standards. As part of the RTR process, this Tradebe facility was selected for a site visit for three primary reasons: (1) it is one of several OSWRO facilities in the Chicago, IL area, which would enable the EPA to see several facilities in one trip, (2) based on available emissions data in the EPA's National Emissions Inventory (NEI), this facility had one of the higher emission rates of the OSWRO facilities identified in that database, and (3) understanding of the facility suggests that this facility is similar to, but different than, and has other operations than the Clean Harbors, Dolton, IL facility.

PLANT SITE OVERVIEW

      The Tradebe Environmental Services, LLC facility is located at 4343 Kennedy Avenue, East Chicago, IN, which is in the greater Chicago, IL area. Tradebe is a hazardous waste management and recycling company. The company's core business at the East Chicago location is recycling. At this site, Tradebe receives waste, including solvents, solvent mixtures, solid and semi-solid materials, and aqueous chemicals, and processes the waste through material handling, fuel blending, and fractional distillation equipment for resale where possible, and waste that is not suitable for onsite treatment is sent offsite to a 3[rd] party facility for incineration, landfill or other means of treatment and/or disposal. The facility is mainly an organic recycling facility. The East Chicago Tradebe facility is also a depack facility. A lab pack is a container consisting of various small containers of chemicals, solvents, industrial supplies, etc. that come from school labs, hospitals, medical facilities, and so on, which must be disposed of properly. The depack facility at Tradebe safely and efficiently handles four specific groups of chemicals (i.e., flammable liquid, corrosive acid, corrosive caustic, flammable solid); with the chemical group processed in individual booths. Tradebe also depacks and consolidates chemicals; the original manufacturer's chemical container is removed from a depack container, evaluated and then placed into a container used for shipping the material off-site. Lastly, the East Chicago Tradebe facility also handles Universal Wastes that are generated by businesses and regulated households. Such waste includes batteries, pesticides and products that contain mercury, such as fluorescent bulbs and thermostats, and this waste is shipped offsite for recovery or disposal. Tradebe's objective is to ship waste for recovery where possible.

      The operations are continuous, with operations occurring 24 hours a day, 7 days a week. The facility receives waste from many businesses. This facility is a RCRA part B plant and also subject to the OSWRO MACT (subpart DD). The Tradebe facility is in a heavy industrial area of East Chicago, IN, roughly 20 miles outside of downtown Chicago, IL.

INFORMATION GATHERED DURING VISIT

	The following section describes the information gathered in relation to the three stated purposes of the visit.

   1. Enhance understanding of current processes and emission controls for the off-site waste and recovery operations (OSWRO) at the facility.

 This facility was previously owned by Pollution Controls Industries, which was acquired by Tradebe Environmental Services in 2008 and renamed to Tradebe in 2011. The facility began operations in 1986 at this location.
 Loads are received via truck. The facility is primarily a drum handling company with a drum storage capacity of 13,750, 55 gallon drums.
 The facility has a tank farm, a lab pack/de-pack facility, a drum consolidation and handling building, recycling units and a non-hazardous processing building. The facility has four distillation units.
 The facility reviews the profile sheets/manifests of the shipments and then samples between 10-100% of the containers received.
 When sampling potentially waste-derived fuel, the facility looks for mercury, the BTU content, chlorine, moisture, PCBs, etc. 30% solids is the limit.
 When materials are approved to come in, they first are evaluated for reuse, (if the material can be used as is). If not, they determine whether it can be distilled (thin film, pot still, liquid and solid distillation) that will create a reusable recycled product. If neither of these activities can be done, the material is sent offsite to an approved 3[rd] party facility for treatment/disposal.
 The facility uses a flare and carbon adsorbers as the primary control devices; there are two small scrubbers and a baghouse in the depack building and two baghouses in use at the site.
 However with carbon being expensive, according to Tradebe personnel, the facility is evaluating a non-regenerative thermal oxidizer. Tradebe indicated the thermal oxidizer is expensive and that it will be a big decision whether to purchase it. If a purchase is made, Tradebe will provide information on the thermal oxidizer to the EPA.

   1. Gain an understanding of the other applicable Clean Air Act regulations for the facility, including 40 CFR 264, 265, 279 and 40 CFR Parts 60, 61 and 63.

 The facility complies with the RCRA standards at 40 CFR part 264, subparts AA, BB, and CC. The facility representatives indicated that the requirements of the RCRA standards were nearly identical to the 40 CFR part 63, subpart DD standards, and that by complying with the RCRA standards, only an additional report or two was required to comply with subpart DD.

   1. Clarify any questions the U.S. EPA has regarding the response received from the recent information collection request for this facility.

 Although not specifically requested in the information collection request, Tradebe noted a concern regarding the current subpart DD equipment leak requirements. Regarding the requirements to physically tag leaking equipment, Tradebe indicated that the tags are expensive, use of man-hours to replace the tags that could sometimes fall off, and in Tradebe's opinion, better methods are available that would achieve the same goal (i.e., on site schematics). Ms. LaGrimas indicated she would send an e-mail with these specific concerns for the EPA's equipment leaks group to consider.


[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Rules and Regulations]
[Pages 60675-60679]
[FR Doc No: 2017-27630]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2017-0146; FRL-9972-06-OAR]
RIN 2060-AT69

Approval of Tennessee's Request To Relax the Federal Reid Vapor
Pressure (RVP) Gasoline Volatility Standard for Shelby County (Memphis)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a request from the state of Tennessee for EPA to
relax the Reid Vapor Pressure (RVP) standard applicable to gasoline
introduced into commerce from June 1 to September 15 of each year
(summertime ozone season) in Shelby County, Tennessee (the Memphis
Area). Specifically, EPA is approving amendments to the regulations to
allow the gasoline RVP standard for Shelby County to rise from 7.8
pounds per square inch (psi) to 9.0 psi. EPA has determined that this
change to the federal RVP regulation is consistent with the applicable
provisions of the Clean Air Act (CAA).

DATES: This final rule is effective on January 22, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2017-0461. All documents in the docket are listed on the
www.regulations.gov website. Although listed in the index, some
information may not be publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available
electronically through www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: David Dickinson, Office of
Transportation and Air Quality, U.S. Environmental Protection Agency,
1200 Pennsylvania Avenue, Washington, DC 20460; telephone number: (202)
343-9256; email address: [email protected], or Rudolph Kapichak,
Office of Transportation and Air Quality, U.S. Environmental Protection
Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number:
(734) 214-4574; email address: [email protected].

SUPPLEMENTARY INFORMATION:
    The contents of this preamble are listed in the following outline:

I. General Information
II. Action Being Taken
III. History of the Gasoline Volatility Requirement
IV. EPA's Policy Regarding Relaxation of Gasoline Volatility
Standards in Ozone Nonattainment Areas That Are Redesignated as
Attainment Areas
V. Tennessee's Request To Relax the Federal Gasoline RVP Requirement
for Shelby County
VI. Final Action
VII. Statutory and Executive Order Reviews
VIII. Legal Authority and Statutory Provisions

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this rule are fuel producers and
distributors who do business in Shelby County.

------------------------------------------------------------------------
      Examples of potentially  regulated entities        NAICS \1\ codes
------------------------------------------------------------------------
Petroleum refineries...................................           324110
Gasoline Marketers and Distributors....................   424710, 424720
Gasoline Retail Stations...............................           447110
Gasoline Transporters..................................   484220, 484230
------------------------------------------------------------------------
\1\ North American Industry Classification System.

    The above table is not intended to be exhaustive, but rather
provides a guide for readers regarding entities likely to be regulated
by this action. The table lists the types of entities of which EPA is
aware that potentially could be affected by this rule. Other types of
entities not listed on the table could also be affected by this rule.
To determine whether your organization could be affected by this rule,
you should carefully examine the regulations in 40 CFR 80.27. If you
have questions regarding the applicability of this action to a
particular entity, see the FOR FURTHER INFORMATION CONTACT section of
this preamble.

B. What is EPA's authority for taking this action?

    The statutory authority for this action is granted to EPA by
Sections 211(h) and 301(a) of the CAA, as amended; 42 U.S.C. 7545(h)
and 7601(a).

II. Action Being Taken

    This final rule approves a request from the state of Tennessee to
change the summertime gasoline RVP standard for Shelby County (the
Memphis Area) from 7.8 psi to 9.0 psi by amending EPA's regulations at
40 CFR 80.27(a)(2). Tennessee did not request relaxation of the federal
RVP standard from 7.8 psi to 9.0 psi when it submitted the CAA section
175A maintenance plan for the 2008 ozone national ambient air quality
standard (NAAQS) that was approved on June 23, 2016 (81 FR 40816). In a
subsequent rulemaking, based on Tennessee's April 12, 2017 request, EPA
approved a CAA section 110(l) non-interference demonstration that
relaxing the federal RVP gasoline requirement from 7.8 psi to 9.0 psi
for gasoline sold from June 1 to September 15 of each year would not
interfere with maintenance of the NAAQS in Shelby County. For more
information on EPA's approval of Tennessee's CAA section 110(l) non-
interference demonstration for Shelby County, please refer to the July
7, 2017 rulemaking (82 FR 31462).
    The preamble for this rulemaking is organized as follows: Section
III, provides the history of the federal gasoline volatility
regulation; Section IV, describes the policy regarding relaxation of
volatility standards in ozone nonattainment areas that are redesignated
as attainment areas; Section V, provides information specific to
Tennessee's request for Shelby County; and Section VI, presents the
final action in response to Tennessee's request.

III. History of the Gasoline Volatility Requirement

    On August 19, 1987 (52 FR 31274), EPA determined that gasoline
nationwide was becoming increasingly volatile, causing an increase in
evaporative emissions from gasoline-powered vehicles and equipment.
Evaporative emissions from gasoline, referred to as volatile organic
compounds (VOCs), are precursors to the formation of tropospheric ozone
and contribute to the nation's ground-level ozone problem. Exposure to
ground-level ozone can reduce lung function, thereby aggravating asthma
and other respiratory conditions, increase susceptibility to
respiratory infection, and may contribute to premature death in people
with heart and lung disease.
    The most common measure of fuel volatility that is useful in
evaluating gasoline evaporative emissions is RVP. Under CAA section
211(c), EPA promulgated regulations on March 22, 1989 (54 FR 11868)
that set maximum limits for the RVP of gasoline sold during the
regulatory control periods that were established on a state-by-state
basis in the final rule. The regulatory control periods addressed the
portion of the year when peak ozone concentrations were expected. These
regulations constituted Phase I of a two-phase nationwide program,
which was designed to reduce the volatility of gasoline during the high
ozone season. On June 11, 1990 (55 FR 23658), EPA promulgated more
stringent volatility controls as Phase II of the volatility control
program. These requirements established maximum gasoline RVP standards
of 9.0 psi or 7.8 psi (depending on the state, the month, and the
area's initial ozone attainment designation with respect to the 1-hour
ozone NAAQS).
    The 1990 CAA Amendments established a new section 211(h) to address
fuel volatility. CAA section 211(h) requires EPA to promulgate
regulations making it unlawful to sell, offer for sale, dispense,
supply, offer for supply, transport, or introduce into commerce
gasoline with an RVP level in excess of 9.0 psi during the high ozone
season. CAA section 211(h) also prohibits EPA from establishing a
volatility standard more stringent than 9.0 psi in an attainment area,
except that EPA may impose a lower (more stringent) standard in any
former ozone nonattainment area redesignated to attainment.
    On December 12, 1991 (56 FR 64704), EPA modified the Phase II
volatility regulations to be consistent with CAA section 211(h). The
modified regulations prohibited the sale of gasoline with an RVP above
9.0 psi in all areas designated attainment for ozone, effective January
13, 1992. For areas designated as nonattainment, the regulations
retained the original Phase II standards published on June 11, 1990 (55
FR 23658), which included the 7.8 psi high ozone season limitation for
certain areas. As stated in the preamble to the Phase II volatility
controls and reiterated in the proposed change to the volatility
standards published in 1991, EPA will rely on states to initiate
changes to their respective volatility programs. EPA's policy for
approving such changes is described below in Section IV. of this
preamble.
    The state of Tennessee initiated this change by requesting that EPA
relax the 7.8 psi gasoline RVP standard to 9.0 psi for Shelby County.
Accordingly, the state of Tennessee provided a technical demonstration
showing that relaxing the federal gasoline RVP requirements from 7.8
psi to 9.0 psi would not interfere with maintenance of the NAAQS in
Shelby County or with any other applicable CAA requirement. See Section
V. of this preamble for information specific to Tennessee's request for
Shelby County.

IV. EPA's Policy Regarding Relaxation of Gasoline Volatility Standards
in Ozone Nonattainment Areas That Are Redesignated as Attainment Areas

    As stated in the rulemaking for EPA's amended Phase II volatility
standards (56 FR 64706, December 12, 1991), any change in the
volatility standard for a nonattainment area that was subsequently
redesignated as an attainment area must be accomplished through a
separate rulemaking that revises the applicable standard for that area.
Thus, for former 1-hour ozone nonattainment areas where EPA mandated a
Phase II volatility standard of 7.8 psi RVP in the December 12, 1991
rulemaking, the federal 7.8 psi RVP gasoline requirement remains in
effect, even after such an area is redesignated to attainment, until a
separate rulemaking is completed that relaxes the federal RVP gasoline
standard in that area from 7.8 psi to 9.0 psi.
    As explained in the December 12, 1991 (56 FR 64706) rulemaking, EPA
believes that relaxation of an applicable gasoline RVP standard is best
accomplished in conjunction with the redesignation process. In order
for an

ozone nonattainment area to be redesignated as an attainment area, CAA
section 107(d)(3) requires the state to make a showing, pursuant to CAA
section 175A(a), that the area is capable of maintaining attainment for
the ozone NAAQS for ten years. Depending on the area's circumstances,
this maintenance plan will either demonstrate that the area is capable
of maintaining attainment for ten years without the more stringent
gasoline volatility standard or that the more stringent gasoline
volatility standard may be necessary for the area to maintain
attainment of the ozone NAAQS. Therefore, in the context of a request
for redesignation, EPA will not initiate the rulemaking to amend 40 CFR
80.27 to relax the gasoline volatility standard unless the state
specifically requests a relaxation and the maintenance plan
demonstrates to the satisfaction of EPA that the area will maintain
attainment for ten years without the need for the more stringent
volatility standard.

V. Tennessee's Request To Relax the Federal Gasoline RVP Requirement
for Shelby County

    On April 12, 2017, the state of Tennessee, through the Tennessee
Department of Environment and Conservation (TDEC), submitted a CAA
section 110(l) non-interference demonstration which illustrated that
removal of the federal RVP requirement of 7.8 psi for gasoline during
the summertime ozone season for Shelby County would not interfere with
maintenance of any NAAQS, including the 2008 ozone NAAQS. Specifically,
TDEC provided a technical demonstration showing that relaxing the
federal gasoline RVP requirement would not interfere with maintenance
of the ozone NAAQS or with any other applicable requirement of the CAA.
As noted above, Tennessee did not request relaxation of the federal RVP
standard from 7.8 psi to 9.0 psi when it submitted a CAA section 175A
maintenance plan for the 2008 ozone NAAQS that was approved on June 23,
2016 (81 FR 40816). However, the approved maintenance plan included the
use of gasoline with an RVP standard of 9.0 psi. Therefore, a revised
maintenance plan with an RVP standard of 9.0 psi is not needed.
Nevertheless, TDEC has appropriately requested (by its April 21, 2017
letter) that EPA approve its non-interference demonstration and
requested that Shelby County no longer be subject to the federal RVP
standard of 7.8 psi for gasoline during the summertime ozone season.
    On May 11, 2017, EPA proposed to approve the CAA section 110(l)
non-interference demonstration. The proposal provided an opportunity
for the public to comment on the action. See 82 FR 21966. EPA received
no comments on the proposal to approve the non-interference
demonstration for Shelby County. In a July 7, 2017 final rule, EPA
approved Tennessee's non-interference demonstration for Shelby County.
See 82 FR 31462.
    EPA's proposal to amend the applicable gasoline RVP standard from
7.8 psi to 9.0 psi (82 FR 39098, August 17, 2017) was subject to public
notice and comment. EPA received no comment on its proposal. In this
action, EPA is approving Tennessee's request to relax the summertime
ozone season gasoline RVP standard for Shelby County from 7.8 psi to
9.0 psi. Specifically, EPA is amending the applicable gasoline RVP
standard from 7.8 psi to 9.0 psi provided at 40 CFR 80.27(a)(2). This
action to approve Tennessee's request to relax the summertime ozone
season RVP standard for Shelby County from 7.8 psi to 9.0 psi is based
on EPA's July 7, 2017 approval of Tennessee's non-interference
demonstration.

VI. Final Action

    EPA is taking final action to approve Tennessee's request for the
Agency to relax the RVP standard applicable to gasoline introduced into
commerce from June 1 to September 15 of each year in Shelby County from
7.8 psi to 9.0 psi as provided at 40 CFR 80.27(a)(2). This approval is
based on Tennessee's request and EPA's final determination in its July
7, 2017 final rule (82 FR 31462) that Tennessee, as required by CAA
section 110(l), made an adequate demonstration to show that removal of
this federal requirement would not interfere with the ozone NAAQS in
the Shelby County and is consistent with CAA requirements. This action
amends the applicable gasoline RVP standard from 7.8 psi to 9.0 psi
provided at 40 CFR 80.27(a)(2) for Shelby County.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and therefore
was not submitted to the Office of Management and Budget (OMB) for
review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is considered an Executive Order 13771 deregulatory
action. This final rule provides meaningful burden reduction because it
relaxes the federal RVP standard for gasoline in Shelby County,
Tennessee and as a result, fuel suppliers will no longer be required to
provide 7.8 psi lower RVP gasoline anywhere in Tennessee during the
summer months (June 1st through September 15th). Relaxing the
volatility requirements will also be beneficial because this action can
improve the fungibility of gasoline sold in the State of Tennessee by
allowing the gasoline sold in Memphis to be identical to the fuel sold
throughout Tennessee.

C. Paperwork Reduction Act (PRA)

    This action does not impose any information collection burden under
the PRA, because it does not contain any information collection
activities.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. The small entities subject to the
requirements of this action are refiners, importers or blenders of
gasoline that choose to produce or import low RVP gasoline for sale in
Tennessee, and gasoline distributers and retail stations in Tennessee.
This action relaxes the federal RVP standard for gasoline sold in
Shelby County, Tennessee during the summertime ozone season (June 1 to
September 15 of each year) to allow the RVP for gasoline sold in this
county to rise from 7.8 psi to 9.0 psi. This rule does not impose any
requirements or create impacts on small entities beyond those, if any,
already required by or resulting from the CAA section 211(h) RVP
program. We have therefore concluded that this action will have no net
regulatory burden for all directly regulated small entities.

E. Unfunded Mandates Reform Act (UMRA)

    This final rule does not contain an unfunded mandate of $100
million or

more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action
implements mandates that are specifically and explicitly set forth in
CAA section 211(h) without the exercise of any policy discretion by the
EPA.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. This final rule will affect only those refiners,
importers or blenders of gasoline that choose to produce or import low
RVP gasoline for sale in Shelby County and gasoline distributers and
retail stations in the Area. Thus, Executive Order 13175 does not apply
to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk. The EPA has no reason to believe that this
action will disproportionately affect children since Tennessee has
provided evidence that a relaxation of the gasoline RVP will not
interfere with its attainment of the ozone NAAQS for Shelby County, or
any other applicable CAA requirement. By separate action, the EPA has
approved Tennessee's non-interference demonstration regarding its
maintenance plan for the 2008 ozone NAAQS, and that Tennessee's
relaxation of the gasoline RVP standard in Shelby County to 9.0 RVP
will not interfere with any other NAAQS or CAA requirement.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income
or indigenous populations because it does not affect the applicable
ozone NAAQS which establish the level of protection provided to human
health or the environment. This rule relaxes the applicable volatility
standard of gasoline during the summer. The EPA has concluded that the
relaxation will not cause a measurable increase in ozone concentrations
that would result in a violation of any ozone NAAQS including the 2008
ozone NAAQS and the more stringent 2015 ozone NAAQS. Therefore,
disproportionately high and adverse human health or environmental
effects on minority or low-income populations are not an anticipated
result. The results of this evaluation are contained in EPA's proposed
and final rules for Tennessee's non-interference demonstration. A copy
of Tennessee's April 12, 2017 letter requesting that the EPA relax the
gasoline RVP standard, including the technical analysis demonstrating
that the less stringent gasoline RVP would not interfere with continued
maintenance of the 2008 ozone NAAQS in Shelby County, or with any other
applicable CAA requirement, has been placed in the public docket for
this action.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller of the
United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

M. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 20, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This action may not be challenged later in proceedings to enforce
its requirements. See CAA section 307(b)(2).

VIII. Legal Authority and Statutory Provisions

    The statutory authority for this action is granted to EPA by
sections 211(h) and 301(a) of the Clean Air Act, as amended; 42 U.S.C.
7545(h) and 7601(a).

List of Subjects in 40 CFR Part 80

    Environmental protection, Administrative practice and procedures,
Air pollution control, Fuel additives, Gasoline, Motor vehicle and
motor vehicle engines, Motor vehicle pollution, Penalties, Reporting
and recordkeeping requirements.

    Dated: December 15, 2017.
E. Scott Pruitt,
Administrator.
    For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 80--REGULATION OF FUELS AND FUEL ADDITIVES

0
1. The authority citation for part 80 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7521, 7542, 7545, and 7601(a).

0
2. In Sec.  80.27, paragraph (a)(2)(ii) is amended in the table by
revising the entry for ``Tennessee'' and footnote 10 to read as
follows:

Sec.  80.27  Controls and prohibitions on gasoline volatility.

    (a) * * *
    (2) * * *
    (ii) * * *

                                                   Applicable Standards \1\ 1992 and Subsequent Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
                               State                                       May              June             July            August         September
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Tennessee \10\.....................................................             9.0              9.0              9.0              9.0              9.0

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
 * * * * * * *
\1\ Standards are expressed in pounds per square inch (psi).
 * * * * * * *
\10\ The standard for Knox County from June 1 until September 15 in 1992 through June 2, 1994 was 7.8 psi. The standard for the Middle Tennessee Area
  (Davidson, Rutherford, Sumner, Williamson, and Wilson Counties) from June 1 until September 15 in 1992 through June 7, 2017 was 7.8 psi. The standard
  in Shelby County (Memphis Area) from June 1 until September 15 in 1992 through 2017 was 7.8 psi.
 * * * * * * *

[FR Doc. 2017-27630 Filed 12-21-17; 8:45 am]
 BILLING CODE 6560-50-P


Wisconsin.............................................             8,619
------------------------------------------------------------------------

Sec.  97.625  [Amended]

    15. Section 97.625 is amended in paragraph (b)(1) by removing the
figure ``2013'' and adding in its place the figure ``2015''.
    16. Section 97.706 is amended:
    a. In paragraph (c)(3) by removing the words ``paragraphs (c)(1)
and (2)'' and adding in their place the words ``paragraph (c)(1)'' and
designating the first sentence as paragraph (c)(3)(i);
    b. By adding a new paragraph (c)(3)(ii); and
    c. In paragraph (e)(2) by removing the words ``or or'' and adding,
in their place, the word ``or''.
    The addition reads as follows:

Sec.  97.706  Standard requirements.

* * * * *
    (c) * * *
    (3) * * *
    (ii) A TR SO2 Group 2 unit shall be subject to the
requirements under paragraph (c)(2) of this section for the control
period starting on the later of January 1, 2014 or the deadline for
meeting the unit's monitor certification requirements under Sec.
97.730(b) and for each control period thereafter.
* * * * *
    14. Section 97.710 is revised to read as follows:

Sec.  97.710  State SO2 Group 2 trading budgets, new unit
set-asides, Indian country new unit set-aside, and variability limits.

    (a) The State SO2 Group 2 trading budgets, new unit set-
asides, and Indian country new unit set-asides for allocations of TR
SO2 Group 2 allowances for the control periods in 2012 and
thereafter are as follows:

----------------------------------------------------------------------------------------------------------------
                                         SO2 Group 2 trading       New unit set-aside    Indian country new unit
                State                    budget (tons) * for      (tons) for 2012 and      set-aside (tons) for
                                            2012 and 2013                 2013                2012 and 2013
----------------------------------------------------------------------------------------------------------------
Alabama..............................                  216,033                    4,321  .......................
Georgia..............................                  158,527                    3,171  .......................
Kansas...............................                   41,528                      789                       42
Minnesota............................                   41,981                      798                       42
Nebraska.............................                   65,052                    2,537                       65
South Carolina.......................                   88,620                    1,683                       89
Texas................................                  314,021                   15,387                      314
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                         SO2 Group 2 trading       New unit set-aside    Indian country new unit
                State                    budget (tons) * for      (tons) for 2014 and      set-aside (tons) for
                                         2014 and thereafter           thereafter          2014 and thereafter
----------------------------------------------------------------------------------------------------------------
Alabama..............................                  213,258                    4,265  .......................
Georgia..............................                   95,231                    1,905  .......................
Kansas...............................                   41,528                      789                       42
Minnesota............................                   41,981                      798                       42
Nebraska.............................                   65,052                    2,537                       65
South Carolina.......................                   88,620                    1,683                       89

Texas................................                  314,021                   15,387                      314
----------------------------------------------------------------------------------------------------------------
* Each trading budget includes the new unit set-aside and, where applicable, the Indian country new unit set-
  aside and does not include the variability limit.

    (b) The States' variability limits for the State SO2
Group 2 trading budgets for the control periods in 2014 and thereafter
are as follows:

------------------------------------------------------------------------
                                                           Variability
                         State                           limits for 2014
                                                         and thereafter
------------------------------------------------------------------------
Alabama...............................................            38,386
Georgia...............................................            17,142
Kansas................................................             7,475
Minnesota.............................................             7,557
Nebraska..............................................            11,709
South Carolina........................................            15,952
Texas.................................................            56,524
------------------------------------------------------------------------

    15. Section 97.725 is amended by, in paragraph (b)(1), removing the
word ``2013'' and adding, in its place, the word ``2015''.

[FR Doc. 2011-26521 Filed 10-13-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Proposed Rules]
[Pages 51949-51951]
[FR Doc No: 2012-20890]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 21

[Docket No. FDA-2011-N-0252]

Office of the Secretary

45 CFR Part 5b

Privacy Act, Exempt Record System

AGENCY: Office of the Secretary, Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) of the Department of
Health and Human Services (HHS) will be implementing a new system of
records, 09-10-0020, ``FDA Records Related to Research Misconduct
Proceedings, HHS/FDA/OC.'' HHS/FDA proposes to exempt this system of
records from certain requirements of the Privacy Act to protect the
integrity of FDA's scientific misconduct inquiries and investigations
and to protect the identity of confidential sources in such
investigations.

DATES: Submit either electronic or written comments by November 13,
2012. If HHS/FDA receives any significant adverse comments, the Agency
will publish a document withdrawing the direct final rule within 30
days after the comment period ends. HHS/FDA will then proceed to
respond to comments under this proposed rule using the usual notice and
comment procedures.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0252, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Frederick Sadler, Division of Freedom
of Information, Office of Public Information & Library Services, Food
and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-
796-8975<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is implementing a new system of records called the ``FDA
Records Related to Research Misconduct Proceedings.'' The purpose of
this system of records is to implement FDA's responsibilities for
addressing research integrity and misconduct, in accordance with the
Public Health Service (PHS) Policies on Research Misconduct (42 CFR
part 93), for research performed by persons who are FDA employees,
agents of the Agency, or who are affiliated with the Agency by contract
or agreement. The term ``research misconduct'' is defined at 42 CFR
93.103 to mean ``fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research, or in reporting research
results.'' The general policy of the PHS Policies on Research
Misconduct is that ``Research misconduct involving PHS support is
contrary to the interests of the PHS and the Federal government and to
the health and safety of the public, to the integrity of research, and
to the conservation of public funds.'' (42 CFR 93.100(a)). The PHS
Policies on Research Misconduct provide for a number of HHS
administrative actions that can be taken in response to a research
misconduct proceeding, such as the suspension of a contract, debarment,
or an adverse personnel action against a Federal employee (42 CFR
93.407). In addition, under 42 CFR 93.401, FDA shall at any time during
a research misconduct proceeding notify HHS' Office of Research
Integrity (ORI) immediately to ensure that FDA's Office of Criminal
Investigations, HHS Office of Inspector General, the Department of
Justice, or other appropriate law enforcement Agencies, are notified if
there is a reasonable indication of possible violations of civil or
criminal law.
    FDA's new system of records will be modeled after the system of
records maintained by ORI, entitled ``HHS Records Related to Research
Misconduct Proceedings, HHS/OPHS/ORI'' System No. 09-37-0021 (59 FR
36717, July 19, 1994; revised most recently at 75 FR 44847, August 31,
2009).
    FDA's scientific misconduct inquiry and investigation records are
located in the Office of the Chief Scientist in FDA's Office of the
Commissioner. FDA is preparing to organize and operate these records as
a ``system of records'' as that term is defined by the Privacy Act. FDA
is publishing a System of Records Notice (SORN) for this system in the
Federal Register contemporaneous with publication of this proposed
rule.
    Under the Privacy Act (5 U.S.C. 552a), individuals have a right of
access to information pertaining to them which is contained in a system
of records. At the same time, the Privacy Act permits certain types of
systems to be exempt

from some of the Privacy Act requirements. For example, section
552a(k)(2) of the Privacy Act allows Agency heads to exempt from
certain Privacy Act provisions a system of records containing
investigatory material compiled for law enforcement purposes. This
exemption's effect on the record access provision is qualified in that
if the maintenance of the material results in the denial of any right,
privilege, or benefit that the individual would otherwise be entitled
to by Federal law, the individual must be granted access to the
material except to the extent that the access would reveal the identity
of a source who furnished information to the Government under an
express promise that the identity of the source would be held in
confidence. In addition, section 552a(k)(5) of the Privacy Act permits
an Agency to exempt investigatory material from certain Privacy Act
provisions where such material is compiled solely for the purpose of
determining suitability, eligibility, or qualifications for Federal
civilian employment, military service, Federal contracts, or access to
classified information, but only to the extent that the disclosure of
such material would reveal the identity of a source who furnished
information to the Government under an express promise that the
identity of the source would be held in confidence.
    As stated previously in this document, FDA may take administrative
action in response to a research misconduct proceeding and, where there
is a reasonable indication that a civil or criminal fraud may have
taken place, will refer the matter to the appropriate investigative
body. As such, FDA scientific misconduct inquiry and investigative
files are records compiled for law enforcement purposes, and the
subsection (k)(2) exemption is applicable to this system of records.
Moreover, where misconduct inquiry and investigative files are compiled
solely for the purpose of making determinations as to the suitability
for appointment as special Government employees or eligibility for
Federal contracts from PHS Agencies, the subsection (k)(5) exemption is
applicable.
    HHS/FDA is therefore proposing to exempt this system under
subsections (k)(2) and (k)(5) of the Privacy Act from the notification,
access and amendment provisions of the Act (subsections (c)(3), (d)(1)
to (d)(4), (e)(4)(G) and (e)(4)(H), and (f)). As described in the
following paragraphs, the exemptions are necessary in order to maintain
the integrity of the research misconduct proceedings and to ensure that
FDA's efforts to obtain accurate and objective information will not be
hindered. However, consideration would be given to requests for
notification, access, and amendment that are addressed to FDA's
Research Integrity Officer (System Manager) or Privacy Act Coordinator.
The specific rationales for applying each of these exemptions are as
follows:
     Subsection (c)(3). An exemption from the requirement to
provide an accounting of disclosures is needed during the pendency of a
research misconduct proceeding. Release of an accounting of disclosures
to an individual who is the subject of a pending research misconduct
assessment, inquiry or investigation could prematurely reveal the
nature and scope of the assessment, inquiry or investigation and could
result in the altering or destruction of evidence, improper influencing
of witnesses, and other evasive actions that could impede or compromise
the proceeding.
     Subsection (d)(1). An exemption from the access
requirement is needed both during and after a research misconduct
proceeding, to avoid revealing the identity of any source who was
expressly promised confidentiality. Only material that would reveal a
confidential source will be exempt from access. Protecting the identity
of a source is necessary when the source is unwilling to report
possible research misconduct because of fear of retaliation (e.g., from
an employer or coworkers).
     Subsections (d)(2) through (d)(4). An exemption from the
amendment provisions is necessary while one or more related research
misconduct proceedings are pending. Allowing amendment of investigative
records in a pending proceeding could interfere with that proceeding;
even after that proceeding is concluded, an amendment could interfere
with other pending or prospective research misconduct proceedings, or
could significantly delay inquiries or investigations in an attempt to
resolve questions of accuracy, relevance, timeliness, and completeness.
     Subsection (e)(4)(G) and (e)(4)(H). An exemption from the
notification provisions is necessary during the pendency of a research
misconduct proceeding, because notifying an individual who is the
subject of an assessment, inquiry, or investigation of the fact of such
proceedings could prematurely reveal the nature and scope of the
proceedings and result in the altering or destruction of evidence,
improper influencing of witnesses, and other evasive actions that could
impede or compromise the proceeding.
     Subsection (f). An exemption from the requirement to
establish procedures for notification, access to records, amendment of
records, or appeals of denials of access to records, is appropriate
because the procedures would serve no purpose in light of the other
exemptions, to the extent that those exemptions apply.
    As stated previously in this document, FDA's new system of records
will be modeled after the system of records maintained by ORI. ORI has
exempted these records under subsections (k)(2) and (k)(5) of the
Privacy Act from the notification, access, accounting, and amendment
provisions of the Privacy Act, to ensure that these records will not be
disclosed inappropriately (59 FR 36717, July 19, 1994). Likewise, FDA
believes that exempting the new system, ``FDA Records Related to
Research Misconduct Proceedings, HHS/FDA,'' from the same Privacy Act
provisions is essential to ensure that material in FDA's files related
to research misconduct proceedings is not disclosed inappropriately.
Except for information that would reveal the identity of a source who
was expressly promised confidentiality, the access exemption will not
prohibit HHS/FDA from granting respondents' access requests consistent
with the PHS Policies on Research Misconduct (42 CFR Part 93),
including in those cases in which a finding of research misconduct has
become final and an administrative action has been imposed.

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule
published in the final rules section of this issue of the Federal
Register. The direct final rule and this companion proposed rule are
substantively identical. This companion proposed rule provides the
procedural framework to proceed with standard notice-and-comment
rulemaking if the direct final rule receives significant adverse
comment and is withdrawn. FDA is publishing the direct final rule
because we believe the rule is noncontroversial and we do not
anticipate receiving any significant adverse comments.
    A significant adverse comment is one that explains why the rule
would be inappropriate, including challenges to the rule's underlying
premise or approach, or would be ineffective or unacceptable without a
change. In determining whether an adverse comment is significant and
warrants terminating a direct final rulemaking, we will consider
whether the comment

raises an issue serious enough to warrant a substantive response in a
notice-and-comment process in accordance with section 553 of the
Administrative Procedure Act (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered significant or adverse under this procedure. A comment
recommending a regulation change in addition to those in the rule would
not be considered a significant adverse comment unless the comment
states why the rule would be ineffective without the additional change.
In addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of a significant adverse comment.
The comment period for the companion proposed rule runs concurrently
with the comment period of the direct final rule. Any comments received
on this companion proposed rule will also be treated as comments on the
direct final rule. We will not provide additional opportunity for
comment.
    If no significant adverse comment is received in response to the
direct final rule, no further action will be taken related to this
companion proposed rule. Instead, we will publish a document confirming
the effective date within 30 days after the comment period ends, and we
intend the direct final rule to become effective 30 days after
publication of the confirmation notice.
    If FDA receives any significant adverse comments, the Agency will
withdraw the direct final rule within 30 days after the comment period
ends and proceed to respond to all of the comments under this companion
proposed rule using usual notice-and-comment rulemaking procedures. The
Agency will address the comments in a subsequent final rule.
    A full description of FDA's policy on direct final rule procedures
may be found in a guidance document published in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

III. Analysis of Impacts

    HHS/FDA has examined the impacts of the proposed 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
Agencies 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). The Agency believes that this
proposed rule is not a significant regulatory action under Executive
Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule imposes no duties or
obligations on small entities, the Agency proposes to certify that the
final rule would not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``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 $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects

21 CFR Part 21

    Privacy.

45 CFR Part 5b

    Privacy.

    Therefore, the Department of Health and Human Services is proposing
to amend 21 CFR part 21 and 45 CFR part 5b to read as follows:

Title 21

PART 21--PROTECTION OF PRIVACY

    1. The authority citation for 21 CFR part 21 continues to read as
follows:

    Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
    2. Section 21.61 is amended by adding paragraph (d) to read as
follows:

Sec.  21.61  Exempt systems.

* * * * *
    (d) Records in the following Food and Drug Administration Privacy
Act Records Systems are exempt under 5 U.S.C. 552a(k)(2) and (k)(5)
from the provisions enumerated in paragraph (a)(1) through paragraph
(a)(3) of this section: FDA Records Related to Research Misconduct
Proceedings, HHS/FDA/OC, 09-10-0020.

Title 45

PART 5b--PRIVACY ACT REGULATIONS

    3. The authority citation for 45 CFR part 5b continues to read as
follows:

    Authority: 5 U.S.C. 301, 5 U.S.C. 552a.

    4. Section 5b.11 is amended by adding paragraph (b)(2)(vii)(C) to
read as follows:

Sec.  5b.11  Exempt systems.

* * * * *
    (b) * * *
    (2) * * *
    (vii) * * *
    (C) FDA Records Related to Research Misconduct Proceedings, HHS/
FDA/OC.
* * * * *

    Dated: July 20, 2012.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2012-20890 Filed 8-27-12; 8:45 am]
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[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Proposed Rules]
[Pages 19599-19601]
[FR Doc No: 2021-07606]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0077]
RIN 1625-AA11

Regulated Navigation Area; Biscayne Bay Causeway Island Slip,
Miami Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a Regulated
Navigation Area over certain navigable waters of the Biscayne Bay
Causeway Island Slip, immediately west of the Coast Guard Base Miami
Beach, Miami Beach, FL. This action is necessary to provide for the
safety of life and federal property on this navigable water. This
proposed rulemaking would require all persons and vessels to transit
the Regulated Navigation Area at a speed that creates minimum wake,
seven miles per hour or less, to safeguard damage to Coast Guard
assets, disrupting operations, and/or injuring Coast Guard personnel.
Additionally, this proposed rulemaking would prohibit vessels from
passing other vessels making way within the regulated area. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 14, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0077 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LT Samuel Rodriguez, Sector Miami
Waterways Management Division, Coast Guard at<PHONE_NUMBER> or by email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background, Purpose, and Legal Basis

    In October 2020, the Fisher Island Ferry Communities Association
relocated its ferry terminal to the Biscayne Bay Causeway Island Slip
(Slip), west of the Coast Guard Base Miami Beach, Miami Beach, FL. The
Slip is the primary terminal for the movement of residents, workers,
and goods from Terminal Island to Fisher Island. Prior to October 2020,
maritime traffic in the Biscayne Bay Causeway Island Basin (Basin) was
limited in scope to occasional private yachts and Coast Guard assets.
The addition of ferry traffic at the Slip has resulted in a substantial
increase in maritime traffic in the Basin. The Basin has a length of
approximately 380 yards and a width of approximately 97 yards. The
increase in traffic, particularly of the Fisher Island Ferry, presents
a hazard to Coast Guard assets operating in the Basin as the ferries
occasionally pass within the Basin, dangerously close to Coast Guard
assets. Additionally, and particularly when passing within the Basin,
the ferries create a disrupting, and at times dangerous wake, adversely
affecting Coast Guard routine operations and personnel. The passing
maneuvers and resultant wake also create hazardous conditions during
certain cutter operations, such as onloading and offloading of
ammunition or refueling. The Coast Guard's Seventh District Commander
has determined the increased ferry traffic, passing maneuvers, and
resultant wake presents a safety and operational concern to Coast Guard
personnel and assets moored in the Biscayne Bay Causeway Island Basin.
    The purpose of this regulation is to ensure navigational safety,
protection of Coast Guard assets and personnel, and to facilitate safe
execution of Coast Guard statutory missions. The Coast Guard is
proposing this rulemaking under authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The Coast Guard's Seventh District Commander is proposing to
establish a permanent Regulated Navigation Area that would require all
persons and vessels to transit the regulated area at a speed that
creates minimum wake, seven miles per hour or less, to safeguard damage
to Coast Guard assets, disrupting operations, and/or injuring Coast
Guard personnel. Additionally, this proposed rulemaking would prohibit
vessels from passing other vessels making way within the regulated
area. This Regulated Navigation Area covers all navigable waters within
the Biscayne Bay Causeway Island Slip, immediately west of the Coast
Guard Base Miami Beach, Miami Beach, FL.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size, and
location of the Regulated Navigation area. The Regulated Navigation
Area will only affect vessels entering, and passing within, the
Biscayne Bay Causeway Island Slip in Miami Beach, Miami Beach, FL.
Vessels will continue to operate within the Biscayne Bay Causeway
Island Slip with the only restriction being the requirement to operate
at speeds below seven miles per hour and avoid passing other vessels
making way within the regulated area. Moreover, upon activating the
Regulated Navigation Area, the Coast Guard will notify the local
maritime community through various means including, Local Notice to
Mariners and Broadcast Notice to Mariners issued on VHF-FM marine radio
channel 16.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not

have a significant economic impact on a substantial number of small
entities.
    While some owners or operators of vessels intending to operate
within the Regulated Navigation Area may be small entities, for the
reasons stated in section IV.A above, this proposed rule would not have
a significant economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    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. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. 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.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a
Regulated Navigation Area requiring all persons and vessels to transit
the regulated area at a speed that creates minimum wake, seven miles or
less, and to avoid passing other vessels making way within the
regulated area. Normally such actions are categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of
Environmental Consideration supporting this determination is available
in the docket. For instructions on locating the docket, see the
ADDRESSES section of this preamble. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.789 to read as follows:

Sec.  165.789   Regulated Navigation Area; Biscayne Bay Causeway Island
Slip, Miami Beach, FL.

    (a) Regulated Area. The following area is a Regulated Navigation
Area: All

waters of Biscayne Bay Causeway Island Slip within the following
points: Beginning at Point 1 in position 25[deg]46'18'' N,
080[deg]08'50'' W; thence east to Point 2 in position 25[deg]46'19'' N,
080[deg]08'47'' W; thence southeast to Point 3 in position
25[deg]46'10'' N, 080[deg]08'41'' W; thence west to Point 4 in position
25[deg]46'10'' N, 080[deg]08'45'' W; thence back to origin at Point 1.
    (b) Regulations. (1) The general regulations governing Regulated
Navigation Areas found in 33 CFR 165.10, 165.11, and 165.13, including
the Regulated Navigation Area described in paragraph (a) of this
section and the following regulations, apply.
    (2) All persons and vessels are required to transit the Regulated
Navigation Area at a speed that creates minimum wake, seven miles per
hour or less, to prevent damage to Coast Guard assests, disrupting
operations, and/or injuring Coast Guard personnel.
    (3) All persons and vessels are required to avoid passing other
vessels making way within the Regulated Navigation Area.
    (c) Enforcement. The Coast Guard may be assisted in the patrol and
enforcement of the Regulated Navigation Area by other Federal, State,
and local agencies.

    Dated: April 6, 2021.
E.C. Jones,
Rear Admiral, U.S. Coast Guard, District Commander.
[FR Doc. 2021-07606 Filed 4-13-21; 8:45 am]
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