[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Rules and Regulations]
[Page 66573]
[DOCID:fr16de09-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

[Docket No. FDA-2009-N-0665]

New Animal Drugs; Change of Sponsor; Ketamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for an abbreviated new
animal drug application (ANADA) for ketamine hydrochloride injectable
solution from Bioniche Animal Health USA, Inc., to Bioniche Teoranta.

DATES: This rule is effective December 16, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Bioniche Animal Health USA, Inc., 119 Rowe
Rd., Athens, GA 30601, has informed FDA that it has transferred
ownership of, and all rights and interest in, ANADA 200-257 for
Ketamine HCl (ketamine hydrochloride injection, USP) to Bioniche
Teoranta, Inverin, County Galway, Ireland. Accordingly, the agency is
amending the regulations in 21 CFR 522.1222a to reflect the transfer of
ownership.
    In addition, Bioniche Teoranta is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
sponsor.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically
add a new entry for ``Bioniche Teoranta''; and in the table in
paragraph (c)(2) numerically add a new entry for ``063286'' to read as
follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
Bioniche Teoranta, Inverin, County Galway,    063286
 Ireland
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
063286                       Bioniche Teoranta, Inverin, County Galway,
                              Ireland
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.1222a  [Amended]

0
4. In paragraph (b) of Sec.  522.1222a, remove ``064847'' and add in
its place ``063286''.

    Dated: December 10, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29888 Filed 12-15-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 162 (Wednesday, August 23, 2023)]
[Rules and Regulations]
[Pages 57331-57333]
[FR Doc No: 2023-18121]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 88, No. 162 / Wednesday, August 23, 2023 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1042; Project Identifier MCAI-2023-00274-A;
Amendment 39-22518; AD 2023-15-06]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Pilatus Aircraft Ltd. (Pilatus) Model PC-24 airplanes. This AD was
prompted by reports of an electrical burning smell in the cabin without
the presence of smoke. This AD requires revising the Limitations
Section of the existing airplane flight manual (AFM) for your airplane,
as specified in a European Union Aviation Safety Agency (EASA) AD,
which is proposed for incorporation by reference (IBR). The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective September 27, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
27, 2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1042; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For EASA service information identified in this final
rule, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +49 221 8999 000; email: [email protected]; website:
easa.europa.eu. You may find this material on the EASA website:
ad.easa.europa.eu.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2023-1042.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Pilatus Model PC-24
airplanes. The NPRM published in the Federal Register on May 15, 2023
(88 FR 30909). The NPRM was prompted by AD 2023-0038, dated February
14, 2023, issued by EASA, which is the Technical Agent for the Member
States of the European Union (referred to after this as ``the MCAI'').
The MCAI states that there have been reports of an electrical burning
smell in the cabin without the presence of smoke and there is currently
no AFM procedure for addressing this condition. The current AFM
procedure for smoke/fume in the cockpit and/or cabin requires the
immediate use of supplemental oxygen and smoke goggles for the flight
crew, which leads to increased flight crew workload. Failure to revise
the AFM to include a new task addressing an electrical burning smell in
the cabin without the presence of smoke could result in an unsafe
condition.
    In the NPRM, the FAA proposed to provide the flight crew with a new
procedure in the existing AFM for your airplane to address the presence
of an electrical burning smell in the cabin without the presence of
smoke. This condition, if not addressed, could lead to increased pilot
workload, possibly resulting in a reduction of safety margins and an
emergency landing. You may examine the MCAI in the AD docket at
regulations.gov under Docket No. FAA-2023-1042.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from one commenter, Pilatus. The
following presents the comment received on the NPRM and the FAA's
response to the comment.

Request To Revise Emergency Procedures Instead of Limitations Section

    Pilatus commented that Section 2, Limitations, of the AFM is not
affected by this new procedure, but Section 3, Emergency Procedures,
is. The FAA infers that the commenter is requesting that the
information in Pilatus PC-24 AFM Temporary Revision 02371-055 (AFM TR
02371-055) be inserted in Section 3A, Abnormal Procedures within the
Emergency Procedures Section of the AFM and not in the Limitations
Section.
    The FAA agrees that AFM TR 02371-055 affects Section 3A, Abnormal
Procedures, of the AFM, but FAA regulations do not mandate compliance
with the Abnormal Procedures Section of the AFM. As explained in the
``Differences Between this AD and the MCAI'' section of this final
rule, EASA AD 2023-0038 requires inserting AFM TR 02371-055 into the
Abnormal Procedures Section of the AFM, but this AD requires inserting
AFM TR 02371-055 into the Limitations Section of the existing AFM
because FAA regulations mandate compliance with only the operating
limitations section of the flight manual. The FAA did not change this
AD as a result of this comment.

Conclusion

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA reviewed the relevant data,
considered the comment received,

and determined that air safety requires adopting this AD as proposed.
Accordingly, the FAA is issuing this AD to address the unsafe condition
on these products. Except for minor editorial changes, and any other
changes described previously, this AD is adopted as proposed in the
NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2023-0038 requires revising the AFM by inserting a copy of
AFM TR 02371-055 into the Abnormal Procedures Section, informing all
flight crews, and operating the airplane accordingly. This material is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Differences Between This AD and the MCAI

    EASA AD 2023-0038 requires inserting AFM TR 02371-055 into the
Abnormal Procedures Section of the AFM, but this AD requires inserting
AFM TR 02371-055 into the Limitations Section of the existing AFM
because FAA regulations mandate compliance with only the operating
limitations section of the flight manual.
    EASA AD 2023-0038 specifies to ``inform all flight crews and,
thereafter, operating the airplane accordingly'' and this AD does not
specifically require those actions.
    14 CFR 91.9 requires that no person may operate a civil aircraft
without complying with the operating limitations specified in the AFM.
Therefore, including a requirement in this AD to operate the airplane
according to the revised AFM would be redundant and unnecessary.
Further, compliance with such a requirement in an AD would be
impracticable to demonstrate or track on an ongoing basis; therefore, a
requirement to operate the airplane in such a manner would be
unenforceable.

Interim Action

    The FAA considers that this AD is an interim action. If final
action is later identified, the FAA may consider further rulemaking.

Costs of Compliance

    The FAA estimates that this AD affects 97 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revise AFM............................  0.50 work-hour x $85 per              $0          $42.50       $4,122.50
                                         hour = $42.50.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2023-15-06 Pilatus Aircraft Ltd: Amendment 39-22518; Docket No. FAA-
2023-1042; Project Identifier MCAI-2023-00274-A.

(a) Effective Date

    This airworthiness directive (AD) is effective September 27,
2023.

(b) Affected Ads

    None.

(c) Applicability

    This AD applies to Pilatus Aircraft Ltd. Model PC-24 airplanes,
all serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code: 2100, Heating
System.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI states that there have been reports of an
electrical burning smell in the cabin without the presence of smoke
and there is currently no airplane flight manual (AFM) procedure for
addressing this condition. The FAA is issuing this AD to provide the
flight crew with a new procedure in the existing AFM for your
airplane to address the presence of an electrical burning smell in
the cabin without the presence of smoke. This condition, if not
addressed, could lead to increased pilot workload, possibly
resulting in a reduction of safety margins and an emergency landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Action

    (1) Except as specified in paragraph (h) of this AD: Comply with
all required actions and compliance times specified in, and in
accordance with, European Union Aviation

Safety Agency (EASA) AD 2023-0038, dated February 14, 2023 (EASA AD
2023-0038).
    (2) The actions required by paragraph (g)(1) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)
and 91.417(a)(2)(v). The record must be maintained as required by 14
CFR 91.417, 121.380, or 135.439.

(h) Exceptions to EASA AD 2023-0038

    (1) Where EASA AD 2023-0038 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (1) of EASA AD 2023-0038 specifies to
``amend the AFM by inserting a copy of the AFM TR,'' this AD
requires replacing those words with ``revise the Limitations Section
of the existing AFM for your airplane by inserting a copy of the AFM
TR as defined in EASA AD 2023-0038.''
    (3) Where paragraph (1) of EASA AD 2023-0038 specifies to
``inform all flight crews and, thereafter, operate the [airplane]
accordingly,'' this AD does not require those actions.
    (4) This AD does not adopt the Remarks paragraph of EASA AD
2023-0038.

(i) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Validation Branch, send it to the
attention of the person identified in paragraph (j) of this AD or
email to: [email protected]. If mailing information, also
submit information by email. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the responsible Flight Standards Office.

(j) Additional Information

    For more information about this AD, contact Doug Rudolph,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Union Aviation Safety Agency AD 2023-0038, dated
February 14, 2023.
    (ii) [Reserved]
    (3) For EASA AD 2023-0038, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 17, 2023.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2023-18121 Filed 8-22-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Notices]
[Pages 39101-39103]
[FR Doc No: 2022-13952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2455]

Patient-Focused Drug Development: Selecting, Developing, or
Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance
for Industry, Food and Drug Administration Staff, and Other
Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Patient-
Focused Drug Development: Selecting, Developing, or Modifying Fit-for-
Purpose Clinical Outcome Assessments.'' This guidance (Guidance 3) is
the third in a series of four methodological patient-focused drug
development (PFDD) guidance documents that describe how stakeholders
(patients, researchers, medical product developers, and others) can
collect and submit patient experience data and other relevant
information from patients and caregivers to be used for medical product
development and regulatory decision-making. When finalized, Guidance 3
will represent the current thinking of the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and Research, and the
Center for Devices and Radiological Health on this topic.

DATES: Submit either electronic or written comments on the draft
guidance by September 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or

anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2455 for ``Patient-Focused Drug Development: Selecting,
Developing, or Modifying Fit-for-Purpose Clinical Outcome
Assessments.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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 to 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: Shannon Cole, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-
796-9208, [email protected]; 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,
240-402-7911; or Office of Strategic Partnerships and Technology
Innovation, Center for Devices and Radiological Health, [email protected],<PHONE_NUMBER> or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Patient-Focused Drug Development: Selecting, Developing, or
Modifying Fit-for-Purpose Clinical Outcome Assessments.'' This guidance
(Guidance 3) is the third in a series of four methodological PFDD
guidance documents that describe how stakeholders (patients,
researchers, medical product developers, and others) can collect and
submit patient experience data and other relevant information from
patients and caregivers to be used for medical product development and
regulatory decision-making. For purposes of this guidance a ``medical
product'' refers to a drug (as defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)) intended for human use, a
device (as defined in section 201), or a biological product (as defined
in section 351 of the Public Health Service Act (42 U.S.C. 262)).
    This series of guidance documents is intended to facilitate the
advancement and use of systematic approaches to collect and use robust
and meaningful input that can more consistently inform medical product
development and regulatory decision-making. Guidance 3 discusses
approaches to selecting, modifying, developing, and validating clinical
outcome assessments to measure outcomes of importance to patients in
clinical trials.
    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 ``Patient-
Focused Drug Development: Selecting, Developing, or Modifying Fit-for-
Purpose Clinical Outcome Assessments.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. This guidance
refers to collections of information from ``individuals under treatment
or clinical examination in connection with research,'' which are not
subject to review by OMB under 5 CFR 1320.3(h)(5). Respondents submit
to FDA collections of information to support the medical product's

effectiveness and to support claims in approved medical labeling.
    The collections of information in 21 CFR 314.50, 314.126, and 601.2
are submitted to FDA to support the medical product's effectiveness and
to support claims in approved medical product labeling. The collections
of information have been approved under OMB control numbers 0910-0001
and 0910-0338. The collections of information in 21 CFR 312.23
regarding investigational new drug applications, including clinical
trial design and study protocols, have been approved under OMB control
number 0910-0014. The collections of information in 21 CFR parts 50 and
56 regarding institutional review boards and the protection of human
subjects have been approved under OMB control number 0910-0130. The
collections of information in 21 CFR part 11 regarding electronic
records and signatures have been approved under OMB control number
0910-0303. The collections of information described in FDA's guidance
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products''` (https://www.fda.gov/media/109951/download) have
been approved under OMB control number 0910-0429.

III. Additional Information

    Section 3002 of Title III, Subtitle A, of the 21st Century Cures
Act (Pub. L. 114-255) directs FDA to develop patient-focused drug
development guidance to address a number of areas, including under
section 3002(c)(2): Methodological approaches that may be used to
develop and identify what is important to patients with respect to
burden of disease, burden of treatment, and the benefits and risks in
the management of the patient's disease.
    In addition, FDA committed to meet certain performance goals under
the sixth authorization of the Prescription Drug User Fee Act. These
goal commitments were developed in consultation with patient and
consumer advocates, healthcare professionals, and other public
stakeholders, as part of negotiations with regulated industry. Section
J.1 of the commitment letter, ``Enhancing the Incorporation of the
Patient's Voice in Drug Development and Decision-Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines work, including the development of a series of
guidance documents and associated public workshops to facilitate the
advancement and use of systematic approaches to collect and use robust
and meaningful patient and caregiver input that can more consistently
inform drug development, and, as appropriate, regulatory decision-
making.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13952 Filed 6-29-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44884-44885]
[FR Doc No: 2020-16082]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG20-214-000.
    Applicants: Saint Solar, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Saint Solar, LLC.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5075.
    Comments Due: 5 p.m. ET 8/10/20.

    Docket Numbers: EG20-215-000.
    Applicants: Hunter Solar LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Hunter Solar LLC.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5105.
    Comments Due: 5 p.m. ET 8/10/20.

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

    Docket Numbers: ER20-2039-001.
    Applicants: GridLiance High Plains LLC.
    Description: Compliance filing: GHP ER20-2039 Resubmission of
Tariff Record to Correct eTariff Filing Issue to be effective 1/27/
2020.
    Filed Date: 7/17/20.
    Accession Number: 20200717-5154.
    Comments Due: 5 p.m. ET 8/7/20.

    Docket Numbers: ER20-2455-000.
    Applicants: SR Platte, LLC.
    Description: Baseline eTariff Filing: MBR Application to be
effective 9/18/2020.
    Filed Date: 7/17/20.
    Accession Number: 20200717-5148.

    Comments Due: 5 p.m. ET 8/7/20.

    Docket Numbers: ER20-2456-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Mid-Atlantic Interstate
Transmision submits IA SA No. 5657 to be effective 9/20/2020.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5065.
    Comments Due: 5 p.m. ET 8/10/20.

    Docket Numbers: ER20-2457-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Original ISA, Service
Agreement No. 5679; Queue No. AF1-189 to be effective 6/18/2020.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5070.
    Comments Due: 5 p.m. ET 8/10/20.

    Docket Numbers: ER20-2458-000.
    Applicants: Hunter Solar LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authority to be effective 9/19/2020.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5084.
    Comments Due: 5 p.m. ET 8/10/20.

    Docket Numbers: ER20-2459-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Tariff Cancellation: Notice of Cancellation of Service
Agreement No. 850 to be effective 9/1/2020.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5088.
    Comments Due: 5 p.m. ET 8/10/20.

    Docket Numbers: ER20-2460-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Section 205(d) Rate Filing: Amendment to Tri-State
Rate Schedule No. 100 to be effective 2/26/2020.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5111.
    Comments Due: 5 p.m. ET 8/10/20.

    Docket Numbers: ER20-2461-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Amendment to ISA, SA No.
5633; Queue No. AC2-088/AD1-136 (amend) to be effective 4/9/2020.
    Filed Date: 7/20/20.
    Accession Number: 20200720-5112.
    Comments Due: 5 p.m. ET 8/10/20.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 20, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-16082 Filed 7-23-20; 8:45 am]
BILLING CODE 6717-01-P


FIFRA SCIENTIFIC ADVISORY PANEL

OPEN MEETING

October 24-26, 2006

FIFRA SAP WEB SITE:    HYPERLINK "http://www.epa.gov/scipoly/sap/"  http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number:  OPP 2006-0657

Evaluation of the Resistance Risks from Using 100% Bollgard and Bollgard II Cotton as Part of a Pink Bollworm Eradication Program in the State of Arizona

Holiday Inn Rosslyn at Key Bridge

1900 North Fort Myer Drive

Arlington, VA  22209

Telephone:<PHONE_NUMBER>

FIFRA SAP Chair:

Steven G. Heeringa, Ph.D.

Research Scientist & Director for Statistical Design

University of Michigan Institute for Social Research

P.O. Box 1248

Ann Arbor, MI  48106-1248

Designated Federal Official:

Myrta R. Christian, M.S.

U.S. Environmental Protection Agency

Office of Science Coordination and Policy

FIFRA Scientific Advisory Panel

EPA East Building

1200 Pennsylvania Avenue, N.W.

Washington, D.C.  20460

Tel:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> FIFRA Scientific Advisory Panel Members:

John R. Bucher, Ph.D., D.A.B.T.

Deputy Director

Environmental Toxicology Program, NIEHS

111 T. W. Alexander Drive

P.O. Box 12233, Mail Drop EC-34

Research Triangle Park, NC  27709

Stuart Handwerger, M.D.

Professor of Pediatrics

University of Cincinnati

  Children's Hospital Medical Center

3333 Burnet Avenue

Cincinnati, OH  45229-3039

Gary E. Isom, Ph.D.

Professor of Toxicology

School of Pharmacy & Pharmacal Sciences

Purdue University

575 Stadium Mall Drive

West Lafayette, IN  47907-2091

Kenneth M. Portier, Ph.D.

Program Director, Statistics

American Cancer Society

Statistics & Evaluation Center

National Home Office

1599 Clifton Road, N.E., Rm. 5.406

Atlanta, GA  30329-4251

FQPA Science Review Board Members:

Gary P. Fitt, Ph.D.

Assistant Chief, CSIRO Entomology

Australian Cotton CRC

120 Meiers Road

Indooroopilly, QLD 4068

AUSTRALIA

Andrew Paul Gutierrez, Ph.D.

Professor, Environmental Science, Policy & Management

University of California

Center for the Analysis of Sustainable Agricultural Systems (CASAS)

203A Mulford Hall

Berkeley, CA  94720

Ian V. MacRae, Ph.D.

Associate Professor & Extension Entomologist

University of Minnesota

Northwest Research & Outreach Center

2900 University Ave.

Crookston, MN  56716

Steven L. Peck, Ph.D.

Assistant Professor

Brigham Young University

Department of Integrative Biology

401 WIDB

Provo, UT  84602-5255

Alan S. Robinson, Ph.D.

Head, FAO/IAEA Agriculture & Biotechnology Unit

International Atomic Energy Agency

A-2444  Seibersdorf

AUSTRIA

Linda J. Young, Ph.D.

Professor, Department of Statistics

University of Florida

P.O. Box 110339

Gainesville, FL  32611


[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19658-19659]
[FR Doc No: 2012-7781]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP12-499-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: SW 27019 & 27435 Short-term Amendments to Negotiated
Rate Agreements to be effective 3/20/2012.
    Filed Date: 3/19/12.
    Accession Number: 20120319-5138.
    Comments Due: 5 p.m. ET 4/2/12.

    Docket Numbers: RP12-500-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: JP Morgan Negotiated Rate Filing to be effective 9/30/
2010.
    Filed Date: 3/19/12.
    Accession Number: 20120319-5181.
    Comments Due: 5 p.m. ET 4/2/12.

    Docket Numbers: RP12-501-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: Tenaska Negotiated Rate Filing to be effective 4/1/
2012.
    Filed Date: 3/19/12.
    Accession Number: 20120319-5195.
    Comments Due: 5 p.m. ET 4/2/12.

    Docket Numbers: RP12-502-000.
    Applicants: Hardy Storage Company, LLC.
    Description: Request for Limited Waiver of Filing Date for Annual
Retainage Adjustment Mechanism filing for Hardy Storage Company, LLC
under RP12-502.
    Filed Date: 3/20/12.
    Accession Number: 20120320-5123.
    Comments Due: 5 p.m. ET 3/27/12.

    Docket Numbers: RP12-503-000.
    Applicants: CenterPoint Energy Gas Transmission Company, LLC.
    Description: CenterPoint Energy Gas Transmission Company, LLC
submits tariff filing per 154.204: PTP Tariff Filing to be effective 5/
1/2012.
    Filed Date: 3/21/12.
    Accession Number: 20120321-5018.
    Comments Due: 5 p.m. ET 4/2/12.

    Docket Numbers: RP12-504-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Texas Eastern Transmission, LP submits tariff filing
per 154.204: NJR Negotiated Rate--eff. 4-1-2012 to be effective 4/1/
2012.
    Filed Date: 3/21/12.
    Accession Number: 20120321-5028.
    Comments Due: 5 p.m. ET 4/2/12.

    Docket Numbers: RP12-505-000.
    Applicants: Ozark Gas Transmission, L.L.C.
    Description: Ozark Gas Transmission, L.L.C. submits tariff filing
per 154.204: Negotiated Rate--SW Energy--contract 820131 to be
effective 4/1/2012.
    Filed Date: 3/21/12.
    Accession Number: 20120321-5046.
    Comments Due: 5 p.m. ET 4/2/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-387-001.
    Applicants: Dominion Transmission, Inc.
    Description: DTI--February 17, 2012 Form of Service Agreement
Revision Compliance to be effective 3/19/2012.
    Filed Date: 3/20/12.
    Accession Number: 20120320-5102.
    Comments Due: 5 p.m. ET 4/2/12.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: March 21, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2012-7781 Filed 3-30-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 231 (Thursday, December 1, 2016)]
[Notices]
[Pages 86770-86771]
[FR Doc No: 2016-28885]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2016-93]

Petition for Exemption; Summary of Petition Received; Western
Oklahoma State College

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before December 21, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-8884
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records

notice (DOT/ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Nia Daniels,<PHONE_NUMBER>, 800 Independence
Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 23, 2016.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2016-8884.
    Petitioner: Western Oklahoma State College.
    Section of 14 CFR Affected: 61.156.
    Description of Relief Sought: Western Oklahoma State College
(WOSC), a part 141 pilot school, seeks an exemption for a portion of
the Airline Transport Pilot Certification Training Program (ATP CTP)
ground training requirements and all of the flight simulation training
device requirements set forth in Sec.  61.156. WOSC's proposed course
would only be available for United States Air Force C-17A Globemaster
III qualified military transport pilots and would contain only those
ATP CTP ground training subject areas with differences specific to
civilian air carrier operations. A military pilot who completes this
program would receive a graduation certificate and be eligible to take
the multiengine airplane ATP knowledge test in accordance with Sec.
61.35(a)(2).

[FR Doc. 2016-28885 Filed 11-30-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Proposed Rules]
[Pages 65049-65051]
[FR Doc No: 2019-25677]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0837]
RIN 1625-AA00

Safety Zone; Lower Mississippi River, Mile Markers 229.5 to 230.5
Baton Rouge, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for navigable waters of the Lower Mississippi River from mile
marker (MM) 229.5 to MM 230.5, above Head of Passes. The safety zone is
needed to protect personnel, vessels, and the marine environment on
these navigable waters near Baton Rouge, LA, during a New Year's Eve
fireworks display. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Sector New Orleans. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before December 11, 2019.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0837 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 Lieutenant Justin Maio, Marine
Safety Unit Baton Rouge, U.S. Coast Guard; telephone<PHONE_NUMBER> ext.
230, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

BNM Broadcast Notice to Mariners
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

    On September 25, 2019, the Office of the Mayor-President of Baton
Rouge, Louisiana, notified the Coast Guard that it will be conducting a
fireworks display from 11:55 p.m. on December 31, 2019, through 12:30
a.m. on January 01, 2020, to commemorate the New Year. The fireworks
are to be launched from the East Bank of the Mississippi River in Baton
Rouge, Louisiana, near mile marker 230. Hazards from firework displays
include accidental discharge of fireworks, dangerous projectiles, and
falling hot embers or other debris. The Captain of the Port New Orleans
(COTP) has determined that potential hazards associated with the
fireworks to be used in this display would be a safety concern for
anyone within a half mile of the display.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a half mile of the fireworks before,
during, and after the scheduled event. The Coast Guard is proposing
this rulemaking under

authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 11:30 p.m. on
December 31, 2019, through 12:30 a.m. on January 1, 2020. The safety
zone covers all navigable waters of the Lower Mississippi River in
Baton Rouge, LA, from mile marker (MM) 229.5 to MM 230.5 above Head of
Passes. The duration of the zone is intended to ensure the safety of
persons, vessels, and the marine environment before, during, and after
the scheduled fireworks display. Entry into this zone is prohibited
unless authorized by the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard assigned to units under the operational control
of USCG Sector New Orleans. Vessels requiring entry into this safety
zone must request permission from the COTP or a designated
representative. They may be contacted on VHF-FM Channel 16 or 67, or
through the Marine Safety Unit Baton Rouge Officer of the Day at 225-
281-4789. All persons and vessels permitted to enter this safety zone
must transit at the slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative. The
COTP or a designated representative will inform the public of the
enforcement times and date for this safety zone through Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or
Marine Safety Information Bulletins (MSIBs), as appropriate.

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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. 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), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This temporary
safety zone would only restrict navigation on a one-mile portion of the
Lower Mississippi River for approximately one hour on one evening.
Moreover, the Coast Guard will issue BNMs via VHF-FM marine channel 16
about the zone, and the rule allows vessels to seek permission to enter
the zone

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 transit the
safety zone 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 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 safety
zone lasting one hour that would prohibit entry within a half mile of a
fireworks display. Normally such actions are categorically excluded
from further review under paragraph

L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning
Implementing Procedures. A preliminary Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES. 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 Correspondence
System of Records notice (84 FR 48645, September 26, 2018).
    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.

0
 2. Add Sec.  165.T08-0837 to read as follows:

Sec.  165.T08-0837  Safety Zone; Lower Mississippi River, Mile Markers
229.5 to 230.5, Baton Rouge, LA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Lower Mississippi River from mile marker (MM) 229.5 to MM
230.5 above Head of Passes, Baton Rouge, LA.
    (b) Effective period. This section is effective from 11:30 p.m. on
December 31, 2019, through 12:30 a.m. on January 1, 2020.
    (c) Regulations. (1) Under the general safety zone regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Sector New Orleans (COTP) or a
designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector New
Orleans.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative via VHF-FM
Channel 16 or 67, or through the Marine Safety Unit Baton Rouge Officer
of the Day at<PHONE_NUMBER>.
    (3) All persons and vessels permitted to enter this safety zone
must transit at the slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement times and date
for this safety zone through Broadcast Notices to Mariners (BNMs),
Local Notices to Mariners (LNMs), and/or Marine Safety Information
Bulletins (MSIBs), as appropriate.

    Dated: November 21, 2019.
Kristi M. Luttrell,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2019-25677 Filed 11-25-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 13, 2008 (Volume 73, Number 50)]
[Notices]
[Page 13595-13596]
[DOCID:fr13mr08-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57447; File No. SR-NASDAQ-2007-096]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Approving Proposed Rule Change To Modify the Allocation of the Maximum
Time an Adjudicatory Body May Grant a Company To Regain Compliance with
the Listing Requirements without Modifying the Maximum Time Available
Under Nasdaq Rule 4802

March 6, 2008.

I. Introduction

    On December 4, 2007, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify the allocation of the maximum time an
adjudicatory body may grant an issuer to regain compliance with the
listing requirements. The proposed rule change was published for
comment in the Federal Register on February 1, 2008.\3\ The Commission
received no comments on the proposal. This order approves the proposed
rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 57214 (January 28,
2008), 73 FR 6228.
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II. Description of the Proposal

    Nasdaq Rule 4800 Series sets forth the procedures for review of a
Nasdaq listing determination. Rule 4802(b) provides that an issuer may
file a written request for an exception to any of the standards set
forth in the Rule 4000 Series at any time during the pendency of a
proceeding under the Rule 4800 Series and sets forth the time periods
that an adjudicatory body may grant an issuer to regain compliance with
the listing requirements (``Exception Period'') before they are
delisted. Under the current rules, the Listing Qualifications Panel
(``Panel'') can grant a maximum Exception Period that is the lesser of
180 days from the date that Nasdaq staff sends a delisting letter
(``Staff Determination'') or 90 days from the date of the Panel's
decision in the matter. Similarly, the Nasdaq Listing and Hearing
Review Council (``Listing Council''), when reviewing a Panel decision,
can grant a maximum Exception Period that is the lesser of 180 days
from the date of the Panel decision on review or 60 days from the

date of the Listing Council's decision in the matter. As a result,
while the maximum cumulative exception these bodies can grant under
these provisions is 360 days from the date of the Staff Determination,
Nasdaq notes in its filing that the actual amount of time can vary from
issuer to issuer based on how quickly the issuer is scheduled for a
hearing and the speed with which the Panel and Listing Council
decisions are prepared. The Exchange believes that this variability may
create uncertainty for Nasdaq-listed companies and their investors
regarding the maximum amount of time available under an exception.
    Nasdaq therefore proposes to modify the computation of the maximum
Exception Period permitted under Rule 4802(b). The proposed rule change
would not, however, increase the maximum time available under the
process. The Exchange proposes that the maximum Exception Period that a
Panel could provide would be 180 days from the date of the Staff
Determination, and the maximum Exception Period that the Listing
Council could provide would be 360 days from the date of the Staff
Determination. As under the current rules, these adjudicatory bodies
would continue to be able to grant an issuer a shorter Exception
Period, or no Exception Period at all, based on their analysis of the
applicable facts and circumstances.

III. Discussion

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange
and, in particular, with Section 6(b)(5) of the Act,\4\ which requires,
among other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to, and perfect the mechanism of, a free and open market and a national
market system and, in general, to protect investors and the public
interest.\5\ The Commission also finds that the proposal is consistent
with Section 6(b)(7) of the Act,\6\ in that it provides a fair
procedure for the prohibition or limitation by the Exchange of any
person with respect to access to services offered by the Exchange.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b)(5).
    \5\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

    The Commission believes that it is essential for a national
securities exchange to have an efficient and fair delisting process for
issuers that are not in compliance with Exchange rules and/or the Act.
The Commission believes that the proposed rule change has the effect of
providing for a maximum Exception Period that is consistent for all
issuers and not dependent on the timing of the adjudicatory decision,
while at the same time does not extend the overall maximum time
allotted for a non-compliant issuer to go through the Nasdaq's current
delisting process. Specifically, under the proposal, rather than being
dependent on variable events, such as how quickly an issuer is
scheduled for a hearing and how promptly the Panel and Listing Counsel
issue their decisions, the maximum allowable Exception Period will, in
all cases, be based on the date of the Staff Determination.
    The Commission recognizes that certain individual issuers that have
already gone through the Exchange delisting process might have been
granted a longer Exception Period had they gone through the process
under the proposed new rules. Nevertheless, the Commission emphasizes
that the proposed rules do not in any way increase the maximum time
that could potentially be available to issuers under Nasdaq's existing
delisting process. Further, the Commission believes the proposed rule
change should help to ensure fair application of the rule to all
issuers, consistent with Section 6(b)(7) of the Act,\7\ and should
eliminate some uncertainty for issuers regarding the maximum time that
may be available under an Exception Period.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

    Finally, the Commission notes that the new rules provide that the
Panel and Listing Counsel can allow an Exception Period not to exceed
180 days or 360 days from the Staff Determination, respectively. Thus,
there may still be variation in the Exception Periods that are granted
to issuers, because the Panel and Listing Counsel retain the authority
to grant an issuer a shorter Exception Period than the maximum
allowable period or no Exception Period at all. In this regard, the
Commission expects the Panel and Listing Counsel to only grant an
Exception Period to those issuers who are likely to regain compliance
within the time frame allotted and notes that there is no particular
right under Nasdaq rules for issuers to be allotted any particular
Exception Period. The Commission expects Nasdaq to continue to delist
issuers, who are not meeting Nasdaq continued listing standards, or
complying with Nasdaq rules and/or the Act, in a prompt, efficient and
fair manner in furtherance of Sections 6(b)(5) and 6(b)(7) of the
Act.\8\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b)(5), 78f(b)(7).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\9\ that the proposed rule change (SR-NASDAQ-2007-096) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-4966 Filed 3-12-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Page 26110]
[FR Doc No: 2021-09974]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91786; File No. SR-NYSEArca-2020-105]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Withdrawal of a Proposed Rule Change To List and Trade the Shares of
the Teucrium Water Fund Under NYSE Arca Rule 8.200-E, Commentary .02

May 6, 2021.
    On November 25, 2020, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade the shares of the Teucrium Water
Fund under NYSE Arca Rule 8.200-E, Commentary .02.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The proposed rule change was published for comment in the Federal
Register on December 14, 2020.\3\ On January 14, 2021, pursuant to
Section 19(b)(2) of the Act,\4\ the Commission designated a longer
period within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On March 9, 2021, the
Commission instituted proceedings under Section 19(b)(2)(B) of the Act
\6\ to determine whether to approve or disapprove the proposed rule
change.\7\ The Commission has received comments on the proposed rule
change.\8\ On May 6, 2021, the Exchange withdrew the proposed rule
change (SR-NYSEArca-2020-105).
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    \3\ See Securities Exchange Act Release No. 90608 (December 8,
2020), 85 FR 80854.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 90927, 86 FR 6719
(January 22, 2021).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 91283, 86 FR 14356
(March 15, 2021).
    \8\ Comments received on the proposed rule change are available
at: https://www.sec.gov/comments/sr-nysearca-2020-105/srnysearca2020105.htm.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09974 Filed 5-11-21; 8:45 am]
BILLING CODE 8011-01-P