 [Federal Register Volume 88, Number 164 (Friday, August 25, 2023)] [Proposed Rules] [Pages 58202-58210] [FR Doc No: 2023-18283]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2022-0648, FRL-11358-01-R2]

Approval and Promulgation of Implementation Plans; New York;  Elements of the 2008 and 2015 Ozone National Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

See attached documents


   EO12866_Oil and Gas Proposed CTG Withdrawal 2060-AT76 EconomicsMemo_20171024

Memorandum
TO:	Docket Number EPA-HQ-OAR-2015-0216 (Control Techniques Guideline for the Oil and Natural Gas Industry)

DATE:	       October 24, 2017

SUBJECT: Estimated Avoided Costs and Forgone Emission Reductions Associated with the Potential Withdrawal of the Control Techniques Guidelines for the Oil and Natural Gas Industry

The Environmental Protection Agency (EPA) is potentially withdrawing the Control Techniques Guidelines for the Oil and Natural Gas Industry (CTG), a notice for which was published in the Federal Register on October 27, 2016.  Recommendations in the CTG rely on the conclusions in the 2016 Final Rule "Oil and Natural Gas Sector: Emission Standards for New, Reconstructed and Modified Sources" (2016 Rule), which the agency has since announced would undergo a broad reconsideration. The final CTG does not require facilities in the oil and natural gas industry to adopt specific control technologies, but recommends reasonably available control technology (RACT) for oil and natural gas emission sources in Moderate and higher ozone nonattainment (NA) areas and the Ozone Transport Regions (OTR). The CTG does obligate states in the OTR and those with areas of moderate or higher NA to consider RACT for non-major sources in the oil and gas industry in their state when creating or revising their state implementation plans (SIPs). A withdrawal of the CTG would relieve states from the obligation of considering RACT for the oil and gas industry, but would not relieve states from their obligations under the National Ambient Air Quality Standards (NAAQS).
Because the CTG relies on the 2016 Rule, which is being reconsidered, the EPA believes it is prudent to withdraw the CTG. The EPA believes that this withdrawal will enhance the efficiency of states in revising their SIPs, in part because it may prevent the possibility of states having to revise their SIPs further due to changes in the 2016 Rule during the reconsideration.
When the CTG was published, the EPA also made available an assessment of the emission reductions and net expenditures required by the industry in the hypothetical situation where all affected oil and natural gas emission sources that existed in 2012 and 2014, respectively, adopt the recommended RACT. As the SIP submission deadline for sources covered by the CTG is October 27, 2018, and the deadline to implement the emission controls for the oil and gas sector laid out in the SIP is January 1, 2021, the EPA assumes that there have been no costs expended as a result of the CTG. Under the same assumptions as outlined and explained in the Oil and Natural Gas Industry Estimated Reasonably Available Control Technology Emission Reductions and Cost of Control (CTG Costs), the potential withdrawal of the CTG will result in avoided costs and forgone emission reductions seen in Table 1, below.
Table 1. Summary of Avoided Costs and Forgone Emission Reductions
                  Avoided RACT VOC Cost of Control ($million)
                       Forgone Emission Reductions (tpy)
                                 Capital Costs
                    Annualized Total Costs (w/o savings)[1]
                   Annualized Total Costs (with savings)[2]
                                      VOC
                                    Methane
                                      HAP
                                     $410
                                     $140
                                     $110
                                    80,000
                                    200,000
                                     3,000
 Note that the avoided costs presented here are the estimated costs from the CTG Costs document, however these are in 2016 dollars, and they were previously published in 2012 dollars.
 [1] This is the sum of the avoided capital costs annualized over the lifetime of the individual control technologies at a 7 percent interest rate plus the avoided annual costs.
 2 This is the sum of the avoided capital costs annualized over the lifetime of the individual control technologies at a 7 percent interest rate plus the avoided annual costs minus the forgone revenue from product recovery.


[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29720-29721]
[FR Doc No: 2015-12396]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0482]

Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25
Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms, was
not withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 301-
796-3602<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products with Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.

    FDA has become aware that the drug product listed in the table in
this document is no longer being marketed.

------------------------------------------------------------------------
      Application No.                 Drug                Applicant
------------------------------------------------------------------------
NDA 020908.................  VAGIFEM (estradiol)    Novo Nordisk Inc.,
                              Vaginal Tablets, 25    800 Scudders Mill
                              micrograms.            Rd., Plainsboro, NJ
                                                     08536.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug product listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDA listed in this document are
unaffected by the discontinued marketing of the product subject to this
NDA. Additional ANDAs that refer to this product may also be approved
by the Agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for estradiol vaginal
tablets should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12396 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14540-14543]
[FR Doc No: 2013-05246]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0907; FRL-9379-5]

Cyromazine, Silica Silicates (Silica Dioxide and Silica Gel),
Glufosinate Ammonium, Dioctyl Sodium Sulfosuccinate (DSS) and
Undecylenic Acid (UDA) Registration Review; Draft Human Health and
Ecological Risk Assessments; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's draft human
health and ecological risk assessments for the registration review of
cyromazine, silica silicates (silica dioxide and silica gel),
glufosinate ammonium, dioctyl sodium sulfosuccinate (DSS) and
undecylenic acid (UDA) and opens a public comment period on these
documents. Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed draft risk assessments for each of the subject
chemicals and is making them available for public comment. After
reviewing comments received during the public comment period, EPA will
issue a revised risk assessment, if appropriate, explain any changes to
the draft risk assessment, and respond to comments and may request
public input on risk mitigation. Through this program, EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

DATES: Comments must be received on or before May 6, 2013.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the table in Unit III., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.

Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For information about a particular
pesticide included in this document, contact the Chemical Review
Manager identified in the table in Unit III. for the pesticide of
interest.
    For general questions on the registration review program, contact:
    Jane Scott-Smith, Pesticide Re-evaluation Division (7508P), Office
of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-0048; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

 A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified in the table in Unit
III. for the pesticide of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts and/or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.

II. Authority

    EPA is conducting its registration review of the pesticides
identified in this document pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5). When used in accordance with widespread and commonly
recognized practice, the pesticide product must perform its intended
function without unreasonable adverse effects on the environment; that
is, without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

What action is the agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for cyromazine, silica silicates, glufosinate ammonium,
DSS, and UDA to ensure that they continue to satisfy the FIFRA standard
for registration--that is, that these pesticides can still be used
without unreasonable adverse effects on human health or the
environment.
    At this stage in the registration review process, consistent with
the notice published in the Federal Register of August 17, 2012, (77 FR
49792) (FRL-9356-5), jointly developed with the U.S. Department of
Agriculture (USDA), the National Marine Fisheries Service (NMFS) and
the U.S. Fish and Wildlife Service (USFWS) (``the Services'') to
enhance opportunities for stakeholder input during pesticide
registration reviews and endangered species consultations, draft
environmental risk assessments include a screening-level evaluation of
the potential risks to Federally endangered and threatened species
(hereafter referred to as ``listed species''). EPA intends to complete
a refined assessment of potential risks to individual listed species,
as needed. The refined listed species assessments will be based on the
recommendations of the National Research Council (NRC), which has been
tasked with providing advice on ecological risk assessment tools and
scientific approaches in developing listed species risk assessments
that are compliant with both FIFRA and the Endangered Species Act
(ESA). EPA anticipates that the NRC report, expected in spring 2013,
will provide recommendations to ensure scientific soundness and
maximize the utility of risk assessment refinements for listed species.
Additional information can be found at the following Web site:

http://www.nationalacademies.org/cp/projectview.aspx?key=49396. Useful
refinements to the listed species assessments are expected to include,
but not be limited to, the following: (1) More detailed, species-
specific ecological and biological data; (2) more detailed and accurate
information on chemical use patterns; and (3) sub-county level spatial
proximity data depicting the co-occurrence of potential effects and
listed species and any designated critical habitat.
    If, in the event that a draft risk assessment shows risks of
concern to human health or the environment for a specific chemical, EPA
reserves the right to initiate mitigation at this stage of registration
review. This effort to mitigate a chemical's risks early in the
registration review process is consistent with the Agency's approach
for registration review. Where risks are identified early in the
registration review process and opportunities for early mitigation
exist, the Agency may pursue those opportunities as they arise, rather
then waiting for completion of a chemical's registration review in
order to mitigate risks. The public comment period for the draft risk
assessments allows members of the public to provide comments and
suggestions for revising the draft risk assessments and for reducing
risks.
    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health and
ecological risk assessments for cyromazine, silica silicates,
glufosinate ammonium, DSS, and UDA. Such comments and input could
address, among other things, the Agency's risk assessment methodologies
and assumptions, as applied in these draft risk assessments.
    The Agency will consider all comments received during the public
comment period and make changes, as appropriate, to the draft human
health and ecological risk assessments. EPA will then issue revised
risk assessments, if appropriate, and explain any changes to the draft
risk assessments, and respond to comments. In the Federal Register
notice announcing the availability of the revised risk assessments, if
any of the revised risk assessments indicate risks of concern, the
Agency may provide a comment period for the public to submit
suggestions for mitigating the risks identified in those revised risk
assessments. At present, EPA is releasing registration review draft
risk assessments for the pesticide cases identified in the following
table and further described after the table.

                                Table--Registration Review Draft Risk Assessments
----------------------------------------------------------------------------------------------------------------
  Registration review case name and                              Chemical review manager, telephone number, and
               number                 Pesticide docket ID No.                    Email address
----------------------------------------------------------------------------------------------------------------
Cyromazine, Case  7439.....  EPA-HQ-OPP-2006-0108...  Kelly Ballard,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Dioctyl sodium sulfosuccinate,        EPA-HQ-OPP-2010-1006...  Garland Waleko,
 Case 4029.<PHONE_NUMBER>,
<EMAIL_ADDRESS>Glufosinate Ammonium,...............  EPA-HQ-OPP-2008-0190...  Katie Weyrauch,
Case 7224..................<PHONE_NUMBER>,
<EMAIL_ADDRESS>Silica Silicates, Case 4081  EPA-HQ-OPP-2007-1140...  Laura Parsons,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Undecylenic acid, Case 4095  EPA-HQ-OPP-2011-0910...  Garland Waleko,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>----------------------------------------------------------------------------------------------------------------

Cyromazine

    The registration review docket for cyromazine (EPA-HQ-OPP-2006-
0108) opened in a notice published in the Federal Register of March 28,
2007 (72 FR 14548) (FRL-8118-3). Cyromazine, an insecticide/larvicide,
is a member of the triazine class of chemicals registered for use on a
variety of agricultural food crop as well as non-food uses such as
landscape and greenhouse ornamentals. For cyromazine, the Agency has
conducted a human health risk assessment for both dietary (food and
drinking water) and occupational exposure pathways. The Agency has also
conducted an ecological risk assessment, which includes a screening-
level listed species assessment. EPA acknowledges that further
refinements to the listed species assessment will be completed in
future revisions and requests public comment on specific areas that
will reduce the uncertainties associated with the characterization of
risk to listed species identified in the current assessment.

Dioctyl Sodium Sulfosuccinate (DSS)

    The registration review docket for DSS (EPA-HQ-OPP-2010-1006)
opened in a notice published in the Federal Register of December 22,
2010 (75 FR 80496) (FRL-8857-6). DSS is registered as an insecticide in
pet shampoos and spray products in combination with undecylenic acid.
There are no food uses and, thus, no tolerances are established. DSS is
also used as an inert ingredient in several end-use pesticide products,
disinfectants and sanitizers, and as a wetting agent in industrial,
drug, cosmetic, and food products. The Agency has conducted a
qualitative assessment of both human health and ecological risks,
including listed species for DSS.

Glufosinate Ammonium

    The registration review docket for glufosinate ammonium (EPA-HQ-
OPP-2008-0190) opened in a notice published in the Federal Register of
March 26, 2008 (73 FR 16011) (FRL-8356-4). Glufosinate ammonium is an
herbicide that acts by inhibiting glutamine synthetase, which leads to
poisoning in plants via the overproduction of ammonia. Glufosinate
ammonium is registered for use on a variety of food crops, and is
registered for use on non-crop areas such as golf course turf and spot
treatments on residential lawns. To support the registration review of
glufosinate ammonium, the Agency has conducted a human health risk
assessment via a new use risk assessment for citrus,

pome, and stone fruits completed July 25, 2012, and an addendum
completed on January 24, 2013, that addresses other scenarios not
covered in the July 25, 2012 new use assessment. The Agency has also
conducted an ecological risk assessment, which includes a screening-
level listed species assessment. EPA acknowledges that further
refinements to the listed species assessment will be completed in
future revisions and requests public comment on specific areas that
will reduce the uncertainties associated with the characterization of
risk to listed species identified in the current assessment.

Silica Silicates

    The registration review docket for silica silicates (EPA-HQ-OPP-
2007-1140) opened in a notice published in the Federal Register of
March 26, 2008 (73 FR 16011) (FRL-8356-4). Silica silicates, silicon
dioxide and silica gel, are insecticides and acaracides used in
controlling insects at indoor and outdoor sites including a variety of
crops. Silicon dioxide is diatomaceous earth, a naturally-occurring
material composed of the shells of minute, single-celled algae. Silica
gel is an amorphous form of silicon dioxide. Because of their abrasive
characteristics, both active ingredients affect insects by removing the
oily protective film covering their bodies which normally prevents the
loss of water, leading to death by desiccation. The qualitative human
health risk assessment conducted for the 1991 reregistration
eligibility decision (RED) is still considered to be an adequate
analysis of potential risks to humans. No new human health toxicology
or exposure data were required or are available for silica silicates;
therefore, a new human health risk assessment was not necessary to be
completed for registration review nor is one being made available for
comment at this time. Further, due to low toxicity, and the fact that
silica silicates naturally occur in the environment, the Agency has
conducted a qualitative ecological risk assessment for non-target
terrestrial species. EPA acknowledges that further refinements to the
listed species assessment will be completed in future revisions and
requests public comment on specific areas that will reduce the
uncertainties associated with the characterization of risk to listed
species identified in the current assessment.

Undecylenic Acid (UDA)

    The registration review docket for UDA (EPA-HQ-OPP-2011-0910)
opened in a notice published in the Federal Register of December 21,
2011 (76 FR 79173) (FRL-9329-7). UDA is registered as an insecticide in
pet shampoos and spray products in combination with dioctyl sodium
sulfosuccinate (DSS). There are no food uses and, thus, no tolerances
are established. UDA is approved by the U.S. Food and Drug
Administration (FDA) as an active ingredient in over the counter anti-
fungal products, and it is also used as a flavoring agent. EPA has
conducted a qualitative assessment for both human health and ecological
risks, including listed species for UDA.
    1. Other related information. Additional information on cyromazine,
silica silicates, glufosinate ammonium, DSS, and UDA is available on
the chemical pages for these pesticides in Chemical Search, http://www.epa.gov/pesticides/chemicalsearch/, and in each chemical's
individual docket listed in Table in Unit III. Information on the
Agency's registration review program and its implementing regulation is
available at http://www.epa.gov/oppsrrd1/registration_review/.
    2. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

List of Subjects

    Environmental protection, Pesticides and pests, cyromazine, silica
silicates (silica dioxide and silica gel), glufosinate ammonium
(glufosinate), dioctyl sodium sulfosuccinate (DSS), and undecylenic
acid (UDA), draft risk assessments.

    Dated: Feburary 26, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-05246 Filed 3-5-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36592-36602]
[FR Doc No: 2023-11852]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0577]

Authorization of Emergency Use of a Drug Product During the
COVID-19 Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use
during the COVID-19 pandemic. FDA has issued an Authorization for the
drug product GOHIBIC (vilobelimab) as requested by InflaRx GmbH's
(InflaRx). The Authorization contains, among other things, conditions
on the emergency use of the authorized product. The Authorization
follows the February 4, 2020, determination by the Secretary of Health
and Human Services (HHS), as amended on March 15, 2023, that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect
national security or the health and security of U.S. citizens living
abroad and that involves a novel (new) coronavirus. The virus, now
named SARS-CoV-2, causes the illness COVID-19. On the basis of such
determination, the Secretary of HHS declared on March 27, 2020, that
circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic, pursuant to
the FD&C Act, subject to the terms of any authorization issued under
that section. The Authorization, which includes an explanation of the
reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of April 4, 2023.

ADDRESSES: Submit written requests for a single copy of the EUA to the
Office of Executive Programs, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th
Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request or include a Fax
number to which the Authorization may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Johanna McLatchy, Office of Executive
Programs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, Silver
Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives (among other criteria).

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, U.S. Code, of attack with (A) a
biological, chemical, radiological, or nuclear agent or agents; or (B)
an agent or agents that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to U.S. military forces;
\1\ (3) a determination by the Secretary of HHS that there is a public
health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on FDA's website. Section 564
of the FD&C Act permits FDA to authorize the introduction into
interstate commerce of a drug, device, or biological product intended
for use in an actual or potential emergency when the Secretary of HHS
has declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355,
360(k), 360b, and 360e) or section 351 of the PHS Act (42 U.S.C. 262),
or conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable

circumstances), FDA \2\ concludes: (1) that an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii) of
the FD&C Act, that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. The Authorization

    The Authorization follows the February 4, 2020, determination by
the Secretary of HHS, as amended on March 15, 2023, that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect
national security or the health and security of U.S. citizens living
abroad and that involves a novel (new) coronavirus. The virus, now
named SARS-CoV-2, causes the illness COVID-19. Notice of the
Secretary's determination was provided in the Federal Register on
February 7, 2020 (85 FR 7316) and notice of the Secretary's amended
determination was provided in the Federal Register on March 20, 2023
(88 FR 16644). On the basis of such determination, the Secretary of HHS
declared on March 27, 2020, that circumstances exist justifying the
authorization of emergency use of drugs and biological products during
the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, subject
to the terms of any authorization issued under that section. Notice of
the Secretary's declaration was provided in the Federal Register on
April 1, 2020 (85 FR 18250). Having concluded that the criteria for
issuance of the Authorization under section 564(c) of the FD&C Act are
met, on April 4, 2023, FDA issued an EUA to InflaRx for the drug
product GOHIBIC (vilobelimab), subject to the terms of the
Authorization. The initial Authorization, which is included below in
its entirety after section IV of this document (not including the
authorized versions of the fact sheets and other written materials),
provides an explanation of the reasons for issuance, as required by
section 564(h)(1) of the FD&C Act. Any subsequent reissuance of the
Authorization can be found on FDA's web page at: https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products.

IV. Electronic Access

    An electronic version of this document and the full text of the
Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN05JN23.008

[GRAPHIC] [TIFF OMITTED] TN05JN23.009

[GRAPHIC] [TIFF OMITTED] TN05JN23.010

[GRAPHIC] [TIFF OMITTED] TN05JN23.011

[GRAPHIC] [TIFF OMITTED] TN05JN23.012

[GRAPHIC] [TIFF OMITTED] TN05JN23.013

[GRAPHIC] [TIFF OMITTED] TN05JN23.014

[GRAPHIC] [TIFF OMITTED] TN05JN23.015

[GRAPHIC] [TIFF OMITTED] TN05JN23.016

    Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11852 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19194-19195]
[FR Doc No: 2016-07611]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0643]

Labeling for Biosimilar Products; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Labeling
for Biosimilar Products.'' This draft guidance is intended to assist
applicants in developing draft prescription drug labeling for proposed
biosimilar products. The recommendations for prescription drug labeling
in this guidance pertain only to the prescribing information (commonly
referred to as the package insert). This draft guidance provides an
overview of FDA's recommendations for labeling for biosimilar products
licensed under the Public Health Service Act (PHS Act).

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 June 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-0643 for ``Labeling for Biosimilar Products; Draft Guidance
for Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
    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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993, 301-796-
1042, or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Labeling for Biosimilar Products.'' The Biologics Price
Competition and Innovation Act of 2009 (BCPI Act), enacted as part of
the Patient Protection and Affordable Care Act (Affordable Care Act)
(Pub. L. 111-148) on March 23, 2010, created an abbreviated

licensure pathway for biological products demonstrated to be biosimilar
to or interchangeable with a reference product. Section 351(k) of the
PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the
requirements for an application for a proposed biosimilar product and
an application or supplement for a proposed interchangeable product.
Under section 351(k) of the PHS Act, a proposed biological product that
is demonstrated to be biosimilar to a reference product can rely on
certain existing scientific knowledge about the safety, purity, and
potency of the reference product to support licensure, and this is
reflected in the approach to biosimilar product labeling.
    In this draft guidance, FDA outlines its recommendations for
biosimilar product labeling. A demonstration of biosimilarity means,
among other things, that FDA has determined that there are no
clinically meaningful differences between the proposed product and the
reference product in terms of safety, purity and potency. Accordingly,
biosimilar applicants should incorporate relevant data and information
from the reference product labeling, with appropriate product-specific
modifications as described in the draft guidance.
    We invite comment on the draft guidance, including whether patient
labeling (e.g., Patient Information, Medication Guide, and Instructions
for Use) should include a biosimilarity statement similar to the
statement described in section IV.C.1 of the draft guidance.
    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 current thinking of FDA on labeling for
biosimilar products. 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520).
The collections of information under 21 CFR part 601 for the submission
of a biologics license application under section 351(k) of the PHS Act
have been approved under OMB control number 0910-0719; the collections
of information under 21 CFR 201.57 for the submission of labeling have
been approved under OMB control number 0910-0572; the collections of
information under 21 CFR part 600 for the submission of adverse
experience reporting for licensed biological products and general
records have been approved under OMB control number 0910-0308; and the
collections of information under 21 CFR part 600 for the submission of
MedWatch reporting forms (FDA Form 3500 and FDA Form 3500A) have been
approved under OMB control number 0910-0291.

III. Electronic Access

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

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07611 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Rules and Regulations]
[Pages 26569-26571]
[FR Doc No: 2019-11964]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0435]
RIN 1625-AA00

Safety Zone, Dive Operations; Cape May Canal, Cape May, NJ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 100-yard radius of all vessels and equipment
involved in diving and debris removal operations within the Cape May
Canal in Cape May, New Jersey. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
created by dive operations and debris removal near the railroad bridge
in the Cape May Canal. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Delaware Bay or his designated representative.

DATES: This rule is effective without actual notice from June 7, 2019
through 4 p.m. on June 13, 2019. For the purposes of enforcement,
actual notice will be used from 6 a.m. on June 3, 2019, through June 7,
2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0435 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Edmund Ofalt, U.S. Coast Guard Sector
Delaware Bay, Waterways Management Division; telephone<PHONE_NUMBER>,
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 Information and Regulatory History

    In mid-May, the Coast Guard was notified that part of the fendering
system for the Cape May Canal Railroad Bridge failed and fell into the
Cape May Canal. The bridge owner has contracted services needed to
remove the debris and, with it, the hazard it poses to waterway
users.\1\ Due to potential dangers associated with the debris removal,
the Captain of the Port Delaware Bay (COTP) has determined that a
safety zone is necessary to protect personnel, vessels, and the marine
environment while the debris is recovered.
---------------------------------------------------------------------------

    \1\ While the fallen debris poses a potential hazard to waterway
users, due to the depth of the water, the Coast Guard has determined
that waterway restrictions have not been needed to adequately
address the threat prior to this time. The Coast Guard has been
issuing safety marine information broadcasts every 6 hours to
mariners regarding the hazard.
---------------------------------------------------------------------------

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule. It is impracticable and contrary to the
public interest to publish an NPRM because immediate action is needed
to respond to the potential safety hazards associated with dive
operations and debris removal scheduled to take place on June 3, 2019.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because

immediate action is needed to respond to the potential safety hazards
associated with dive operations and debris removal. The rule must be in
place by the time the dive operations and debris removal occur on June
3, 2019, to protect personnel, vessels, and the marine environment
while the debris is recovered.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP has determined that
potential hazards associated with diving and debris removal operations
starting June 3, 2019, will be a safety concern for anyone within a
100-yard radius of associated dive vessels and working barges. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone during
diving and debris removal operations.

IV. Discussion of the Rule

    This rule establishes a safety zone from 6 a.m. on June 3, 2019
through 4 p.m. on June 13, 2019. The safety zone will cover all
navigable waters within 100 yards of dive vessels and working barges
being used for dive and debris recovery operations. Dive vessels and
working barges refers to those vessels used as dive platforms and 40
foot by 15 foot flexi-float barges utilized for the purpose of debris
removal. The duration of the zone is intended to protect personnel,
vessels, and the marine environment in these navigable waters while the
debris is recovered. No vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP or his
designated representative. Vessels with a beam greater than 15 feet
must contact the working vessels via VHF-FM channel 13 or 16 at least
30 minutes prior to arrival in order to arrange safe passage.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size and
duration of the zone. Small vessels with a beam less than 15 feet will
generally be able to pass through the zone as needed upon receiving
authorization from the COTP or his designated representative. Vessels
with a beam greater than 15 feet will be able to pass through the zone
if at least 30 minutes notice is given prior to arrival. Diving and
debris recovery operations will only take place from 7 a.m. through 4
p.m. daily beginning June 3, 2019 through June 13, 2019.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in

complying with the National Environmental Policy Act of 1969 (42 U.S.C.
4321-4370f), and have determined that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. This rule involves a safety zone that
will prohibit entry within 100 yards of dive vessels and working barges
being used for diving and debris recovery operations in the Cape May
Canal. It is categorically excluded from further review under paragraph
L[60a] in Table 3-1 of U.S. Coast Guard Environmental Planning
Implementing Procedures 5090.1. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 50 U.S.C. 191; 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.T05-0435 to read as follows:

Sec.  165.T05-0435  Safety Zone, Dive Operations; Cape May Canal, Cape
May, NJ.

    (a) Location. The following area is a safety zone: All navigable
waters within 100 yards of dive vessels and working barges being used
for diving and debris recovery operations within the Cape May Canal.
    (b) Definitions As used in this section--
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard petty officer, warrant or commissioned officer
on board a Coast Guard vessel or on board a federal, state, or local
law enforcement vessel assisting the Captain of the Port (COTP),
Delaware Bay in the enforcement of the safety zone.
    Working barges means those vessels associated with debris removal
near the Cape May Canal Railroad Bridge in the Cape May Canal.
    Dive vessels means those vessels used for dive operations, and
marked appropriately in accordance with navigation rules of the road,
which are associated with debris removal near the Cape May Canal
Railroad Bridge in the Cape May Canal.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter or remain in the zone, contact the
COTP or the COTP's representative via VHF-FM channel 16 or 215-271-
4807. Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (3) Vessels with a beam greater than 15 feet must contact working
vessels, via VHF-FM channel 13 or 16, at least 30 minutes prior to
arrival in order to arrange safe passage.
    (4) This section applies to all vessels except those engaged in law
enforcement, aids to navigation servicing, and emergency response
operations.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the safety zone by Federal, State, and local
agencies.
    (e) Enforcement period. This zone will be enforced from 6 a.m. on
June 3, 2019, through 4 p.m. on June 13, 2019.

    Dated: May 31, 2019.
Scott E. Anderson,
Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2019-11964 Filed 6-6-19; 8:45 am]
 BILLING CODE 9110-04-P