[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51328-51330]
[FR Doc No: 2023-16550]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2175]

Raidel Figueroa: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Raidel Figueroa from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Figueroa was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Figueroa was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why he should not be debarred within the
timeframe prescribed by regulation. Mr. Figueroa has not responded to
the notice. Mr. Figueroa's failure to respond and request a hearing
within the prescribed timeframe constitutes a waiver of his right to a
hearing concerning this action.

DATES: This order is effective August 3, 2023.

ADDRESSES: Any application by Mr. Figueroa for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted as follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application, that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

     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 a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All applications must include the Docket No. FDA-
2022-N-2175. Received applications 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 an application with
confidential information that you do not wish to be made publicly
available, submit your application 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 your application. 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. 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, 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 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at<PHONE_NUMBER>,
or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act requires debarment of an
individual from providing services in any capacity to a person that has
an approved or pending drug product application if FDA finds that the
individual has been convicted of a felony under Federal law for conduct
relating to the regulation of any drug product under the FD&C Act. On
August 31, 2022, Mr. Figueroa was convicted in the U.S. District Court
for the Southern District of Florida, Fort Lauderdale Division, when
the court entered a judgment of conviction, after his plea of guilty,
to one count of conspiracy to defraud the United States in violation of
18 U.S.C. 371, one count of falsification of records in a Federal
investigation in violation of 18 U.S.C. 1519, one count of obstruction
of proceedings before an Agency of the United States in violation of 18
U.S.C. 1505, and one count of distribution of adulterated drugs in
interstate commerce in violation of 21 U.S.C. 331(a) (section 301(a) of
the FD&C Act), all felony offenses under Federal law.
    The factual basis for this conviction is as follows: Mr. Figueroa
was the Chief Executive Officer and co-owner of Pharmatech, LLC, a drug
and dietary supplement manufacturer that operated in Broward County,
FL. From at least 2016 through at least March 2017, Pharmatech
manufactured and distributed Diocto Liquid, a drug used to treat
constipation in adults and children. In July 2016, FDA initiated an
inspection at Pharmatech as part of an investigation into an outbreak
of Burkholderia cepacia (B. cepacia) infections. B. cepacia is the name
for a group or ``complex'' of bacteria typically found in soil and
water. These bacteria pose little medical risk to healthy people, but
people who have certain health problems like weakened immune systems or
chronic lung diseases may be more susceptible to B. cepacia infections.
The effects of B. cepacia can include serious respiratory infections
and other types of infections. Contaminated medicines can transmit B.
cepacia, and the bacteria are often resistant to common antibiotics. At
the close of FDA's inspection in August of 2016, FDA notified Mr.
Figueroa that a water sample taken from Pharmatech's water system had
tested positive for the presence of B. cepacia. In his written response
to FDA's inspectional observations, Mr. Figueroa advised FDA that
Pharmatech was re-engineering its purified water system to prevent
contamination of the water used for both production and cleaning
purposes. Following the July-August 2016 FDA inspections, Mr. Figueroa
also temporarily stopped manufacturing liquid products.
    In March 2017, FDA initiated another inspection at Pharmatech. FDA
investigators asked Mr. Figueroa to provide a product list of all
products that Pharmatech had manufactured after it resumed
manufacturing in November 2016. Mr. Figueroa knowingly excluded Diocto
Liquid from Pharmatech's products list that he provided FDA
investigators despite Pharmatech having shipped approximately 7,308
units of the drug earlier that month. When FDA investigators later
discovered that the product list Mr. Figueroa provided them was
incomplete, FDA investigators again requested he provide them with a
complete list. Mr. Figueroa caused a second product list to be produced
to FDA; he again falsely represented to FDA that it was a complete list
when he knew it was false because it omitted Diocto Liquid.
    In April 2017, Mr. Figueroa provided FDA a written memorandum
regarding Pharmatech's water system. That memorandum falsely stated
that all data for Phase 3 testing of Pharmatech's new water system had
met ``acceptance criteria,'' although Mr. Figueroa was aware the water
system had not met acceptance criteria because a water sample taken on
February 15, 2017, tested presumptive positive for the presence of B.
cepacia.
    During this same March-May 2017 inspection, when FDA investigators
requested that Mr. Figueroa identify any other business he owned, he
failed to disclose that he owned and controlled Ofcus Pharma, which was
a company established for the purpose of manufacturing oral solid drugs
and dietary supplements. Mr. Figueroa later asked someone else to tell
FDA investigators that they were the owner of Ofcus Pharma if that firm
was ever inspected by FDA, and not to disclose that Mr. Figueroa was
the owner of Ofcus Pharma.

    In July 2017, the Centers for Disease Control and Prevention
notified FDA of multiple cases of B. cepacia infections in pediatric
patients at Stanford Children's Health Lucile Packard Children's
Hospital in Palo Alto, CA and Johns Hopkins Children's Center in
Baltimore, MD. FDA investigated and collected bottles of Diocto Liquid
from these medical centers. The collected bottles were from the same
lot that Pharmatech distributed in March 2017--the same lot that
Pharmatech failed to disclose to FDA. Several of the bottles contained
total aerobic microbial counts and total yeast and mold counts in
excess of acceptable limits and some of the bottles also tested
positive for the presence of B. cepacia.
    In September 2017, FDA initiated an inspection of Ofcus Pharma.
During that inspection the individual Mr. Figueroa asked to
misrepresent to FDA that they owned Ofcus Pharma, did in fact make
false statements to an FDA investigator when they told the investigator
they had full ownership of Ofcus Pharma.
    Based on this conviction, FDA sent Mr. Figueroa by certified mail
on March 20, 2023, a notice proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act, that Mr. Figueroa was
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act. The proposal also offered Mr. Figueroa
an opportunity to request a hearing, providing him 30 days from the
date of receipt of the letter in which to file the request, and advised
him that failure to file a timely request for a hearing would
constitute an election not to use the opportunity for a hearing and a
waiver of any contentions concerning this action. Mr. Figueroa received
the proposal on March 30, 2023. He did not request a hearing within the
timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and any contentions concerning his debarment
(21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Figueroa has been convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
    As a result of the foregoing finding, Mr. Figueroa is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Mr. Figueroa during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Figueroa provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment he will be subject
to civil money penalties (section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review any abbreviated new drug
application from Mr. Figueroa during his period of debarment, other
than in connection with an audit under section 306 of the FD&C Act
(section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of
sections 306 and 307 of the FD&C Act, a ``drug product'' is defined as
a ``drug subject to regulation under section 505, 512, or 802 of this
Act [(21 U.S.C. 355, 360b, 382)] or under section 351 of the Public
Health Service Act [(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act
(21 U.S.C. 321(dd))).

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16550 Filed 8-2-23; 8:45 am]
BILLING CODE 4161-01-P


[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Page 27425]
[FR Doc No: 2020-09840]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4530-DR; Docket ID FEMA-2020-0001]

Oklahoma; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Oklahoma (FEMA-4530-DR), dated April 5, 2020,
and related determinations.

DATES: The declaration was issued April 5, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 5, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
Oklahoma resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Oklahoma.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, George A. Robinson, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Oklahoma have been designated
as adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of Oklahoma.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-09840 Filed 5-7-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74812-74813]
[FR Doc No: 2014-29402]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA--2014-0130]

Notice of Buy America Waiver

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of Buy America waiver.

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SUMMARY: This Notice provides NHTSA's finding with respect to a request
from the Hawaii Department of Transportation's Motor Vehicle Safety
Office, Highway Safety Section (MVSO) to waive the requirements of Buy
America. NHTSA finds that a cost waiver is appropriate for MVSO to
purchase eight foreign-made training motorcycles using Federal grant
funds because the cost of domestically produced products is twenty-five
percent more than the cost of the foreign-made products.

DATES: The effective date of this waiver is December 26, 2014. Written

comments regarding this notice may be submitted to NHTSA and must be
received on or before: December 31, 2014.

ADDRESSES: Written comments may be submitted using any one of the
following methods:
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Fax: Written comments may be faxed to<PHONE_NUMBER>.
     Internet: To submit comments electronically, go to the
Federal regulations Web site at http://www.regulations.gov. Follow the
online instructions for submitting comments.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. Eastern Time,
Monday through Friday, except Federal holidays.
    Instructions: All comments submitted in relation to this waiver
must include the agency name and docket number. Please note that all
comments received will be posted without change to http://www.regulations.gov, including any personal information provided. You
may also call the Docket at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For program issues, contact Barbara
Sauers, Office of Regional Operations and Program Delivery, NHTSA
(phone:<PHONE_NUMBER>). For legal issues, contact Andrew DiMarsico,
Office of Chief Counsel, NHTSA (phone:<PHONE_NUMBER>). You may send mail
to these officials at the National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: This notice provides NHTSA's finding that a
waiver of the Buy America requirements, 23 U.S.C. 313, is appropriate
for the Hawaii's MVSO to purchase eight training motorcycles using
grant funds authorized under 23 U.S.C. 402 (section 402) and 23 U.S.C.
405(f) (section 405) for training motorcycles. Section 402 funds are
available for use by State Highway Safety Programs to reduce traffic
accidents and deaths, injuries and property damage. 23 U.S.C. 402(a).
Section 405(f) funds are available for use by State Highway Safety
Programs to implement effective programs to reduce the number of single
and multi-vehicle crashes involving motorcyclists that, among other
things, includes supporting training of motorcyclists. 23 U.S.C.
405(f).
    Buy America provides that NHTSA ``shall not obligate any funds
authorized to be appropriated to carry out the Surface Transportation
Assistance Act of 1982 (96 Stat. 2097) or [Title 23] and administered
by the Department of Transportation, unless steel, iron, and
manufactured products used in such project are produced in the United
States.'' 23 U.S.C. 313. However, NHTSA may waive those requirements if
(1) their application would be inconsistent with the public interest;
(2) such materials and products are not produced in the United States
in sufficient and reasonably available quantities and of a satisfactory
quality; or (3) the inclusion of domestic material will increase the
cost of the overall project contract by more than 25 percent. 23 U.S.C.
313(b). In this instance, NHTSA has determined a cost waiver is
appropriate for the eight motorcycles because domestically produced
motorcycles would increase the cost by more than 25 percent.
    MVSO seeks a waiver to purchase two 2015 Suzuki TU250X motorcycles
at $4,399 per unit and six 2013 Suzuki DR200SE motorcycles at $4,299
per unit. The total purchase price for all eight motorcycles is
$36,221. Hawaii's motorcyclist training program is designed to provide
students the ability to learn and practice fundamentals of safe riding
behavior, skills and motorcycle handling. Hawaii asserts that if
students were required to provide their own motorcycles, many people
would be discouraged from taking the safety courses and it would
encourage some individuals to obtain a motorcycle and unsafely operate
it on public roads before they are properly trained and licensed to do
so. MVSO states that having a fleet of training motorcycles available
for use during training ensures that the road skills portion of the
curricula can be taught effectively and is more accessible to the
general public. MVSO desires to use these motorcycles for its
motorcyclist training program because they are designed specifically
with smaller engine displacement (250 CC), which is consistent with
motorcyclist training programs. Hawaii, however, is unable to identify
any training motorcycles that meet the Buy America requirements. MVSO
researched \1\ motorcycle models made by the two American motorcycle
manufacturers, Harley-Davidson, Inc. and Victory Motorcycles. Harley
Davidson produces a 500 CC motorcycle called the Street 500, with a
MSRP of $6799. Victory Motorcycles (including Indian Motorcycles)
produces much heavier and larger engine displacement than 500 CC, with
the lowest MSRP of $12,499 for the Victory Vegas 8-ball motorcycle.
MVSO was unable to find a motorcycle that meets the requirements for
training motorcycles that would meet the Buy America requirements.
NHTSA is unaware of any other domestic motorcycle manufacturers other
than Harley-Davidson and Victory. Since the Harley Davidson Street has
a starting price of $6,799, it is more than 25 percent higher than the
cost of a 2015 Suzuki TU250X and 2013 Suzuki DR200SE motorcycles.
Accordingly, a Buy America waiver is appropriate. NHTSA invites public
comment on this conclusion.
---------------------------------------------------------------------------

    \1\ MVSO states that its Motorcycle Safety Program Coordinator
conducted research via phone calls, emails and Internet searches to
try to identify domestically produced motorcycles.
---------------------------------------------------------------------------

    In light of the above discussion, and pursuant to 23 U.S.C.
313(b)(3), NHTSA finds that it is appropriate to grant a waiver from
the Buy America requirements to MVSO in order to purchase two 2015
Suzuki TU250X and six 2013 Suzuki DR200SE motorcycles. This waiver
applies to Hawaii and all other States seeking to use section 402 and
405 funds to purchase these motorcycles for the purposes mentioned
herein. This waiver will continue through fiscal year 2015 and will
allow the purchase of these items as required for Hawaii's MVSO and its
training programs. Accordingly, this waiver will expire at the
conclusion of fiscal year 2015 (September 30, 2015). In accordance with
the provisions of Section 117 of the Safe, Accountable, Flexible,
Efficient Transportation Equity Act: A Legacy of Users Technical
Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572), NHTSA is
providing this notice as its finding that a waiver of the Buy America
requirements is appropriate for certain Suzuki motorcycles. Written
comments on this finding may be submitted through any of the methods
discussed above. NHTSA may reconsider these findings, if through
comment, it learns of and can confirm the existence of a comparable
domestically made product to the items granted a waiver.
    This finding should not be construed as an endorsement or approval
of any products by NHTSA or the U.S. Department of Transportation. The
United States Government does not endorse products or manufacturers.

    Authority:  23 U.S.C. 313; Pub. L. 110-161.

    Issued in Washington, DC, under authority delegated in 49 CFR
part 1.95.
O. Kevin Vincent,
Chief Counsel.
[FR Doc. 2014-29402 Filed 12-15-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Page 51028]
[FR Doc No: 2020-18145]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2654-000]

Clear Power LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced Clear Power
LLC's application for market-based rate authority, with an accompanying
rate tariff, noting that such application includes a request for
blanket authorization, under 18 CFR part 34, of future issuances of
securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 2, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.

    Dated: August 13, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-18145 Filed 8-18-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 23, 2006 (Volume 71, Number 56)]
[Rules and Regulations]
[Page 14640-14642]
[DOCID:fr23mr06-5]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 385

[Docket No. RM05-33-001]

Revision of Rules of Practice and Procedure Regarding Issue
Identification

AGENCY: Federal Energy Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Federal Energy Regulatory Commission (Commission) is
revising its regulations regarding pleadings. The regulations are
revised to eliminate, in all pleadings except requests for rehearing, a
recent formatting requirement that the pleadings contain a section
entitled ``Statement of Issues.''

DATES: Effective Date: The rule will become effective March 23, 2006.

FOR FURTHER INFORMATION CONTACT: Carol C. Johnson, Office of the
General Counsel, GC-10, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Before Commissioners: Joseph T. Kelliher, Chairman; Nora Mead Brownell,
and Suedeen G. Kelly; Order No. 663-A; Final Rule; Issued March 17,
2006

    1. The Federal Energy Regulatory Commission (Commission) is
revising its rules of practice and procedure to eliminate for all
pleadings, except requests for rehearing, a recent change in Order No.
663 requiring that any issues a filer wishes the Commission to address
be clearly set forth in a section of the pleading entitled ``Statement
of

Issues'' and that ``any issue not so listed will be deemed waived.''
\1\ Several months of experience under the new rule has indicated that
it is not necessary in the context of all pleadings; however the
Commission is retaining the requirement as it applies to Rule 713,
request for rehearing.
---------------------------------------------------------------------------

    \1\ Revision of Rules of Practice and Procedure Regarding Issue
Identification, Order No. 663, 70 FR 55723 at P 5 (September 23,
2005), III FERC Stats. & Regs. ] 31,193 (September 16, 2005).
---------------------------------------------------------------------------

    2. In Order No. 663, the Commission stated that it believed the
changes to 18 CFR 385.203(a)(7) and 385.713 would benefit both the
Commission and participants by providing certainty with respect to
issues being raised. In the meantime, the requirement for a ``Statement
of Issues'' section has not proven particularly helpful for a number of
common pleadings, and has led to confusion on the part of filers. For
instance, many motions to intervene do not contest specific issues in
the pleadings. Filers in those types of situations have puzzled over
what information, if any, belongs in a Statement of Issues for their
motion to intervene. To eliminate this confusion and simplify the
pleadings format, the requirement for a separate Statement of Issues
section is being eliminated from Rule 203. Parties will not be
prejudiced by this formatting change, given that Sec.  385.203(a)(7)
will maintain its original requirement that pleadings include, as
appropriate, ``[t]he position taken by the participant filing any
pleading, to the extent known when the pleading is filed, and the basis
in fact and law for such position. * * *'' This will provide adequate
notice for the issues raised in the pleadings. This rule deletes the
following language from Sec.  385.203(a)(7): ``including a separate
section entitled ``Statement of Issues,'' listing each issue presented
to the Commission in a separately enumerated paragraph that includes
representative Commission and court precedent on which the participant
is relying; any issue not so listed will be deemed waived.''
    3. However, the Commission finds that a ``Statement of Issues''
requirement is necessary in the context of requests for rehearing.
Requiring the party seeking rehearing to specify each issue being
raised in a separate paragraph benefits the Commission by clarifying
the issues it needs to address on rehearing. More importantly, it
benefits parties seeking rehearing. As noted in Order No. 663, both the
Natural Gas Act and Federal Power Act mandate that issues be raised on
rehearing as a jurisdictional prerequisite to obtaining judicial review
of a Commission order.\2\ Order No. 663 at P 4. Courts have found no
jurisdiction to address issues that were not raised on rehearing.\3\
Therefore, the requirement for a separate section specifically
enumerating issues raised on rehearing benefits parties seeking
rehearing because it prevents them from having cases denied on appeal
for failure to clearly raise the issue at the administrative level.
---------------------------------------------------------------------------

    \2\ Section 19(b) of the Natural Gas Act, 15 U.S.C. 717r(b),
states that ``No objection to the order of the Commission shall be
considered by the court unless such objection shall have been urged
before the Commission in the application for rehearing unless there
is reasonable ground for failure to do so.'' Section 313(a) of the
Federal Power Act, 16 U.S.C. 825l(a) states that ``The application
for rehearing shall set forth specifically the ground or grounds
upon which such application is based. * * * No proceeding to review
any orders of the Commission shall be brought by any person unless
such person shall have made application to the Commission for a
rehearing thereon.''
    \3\ See DTE Energy Co. v. FERC, 394 F.3d 954, 960 (DC Cir. 2005)
(finding petitioner's failure to seek rehearing ``fatal'' to its
court challenge, noting that ``[t]he mandatory requirement of filing
a petition for rehearing is designed to afford the Commission an
opportunity to invoke its expertise or to correct any errors prior
to judicial review''); Fuel Safe Washington v. FERC, 389 F.3d 1313
(10th Cir. 2004) (``the presentation of a ground of objection in an
application for rehearing by the Commission is an indispensable
prerequisite to the exercise of power of judicial review of the
order on such ground,'' quoting Pan Am Petroleum Corp. v. FPC, 268
F.2d 827, 830 (10th Cir. 1959)).
---------------------------------------------------------------------------

    4. Moreover, requiring all issues to be set forth with specificity
in separately enumerated paragraphs helps to ensure that the Commission
will adequately address the issues raised in the rehearing request for
purposes of judicial review. As noted in Order No. 663, there are
numerous instances where appeals were denied because the court found
that a petitioner's position was not clearly articulated before the
Commission.\4\
---------------------------------------------------------------------------

    \4\ See, e.g., Intermountain Municipal Gas v. FERC, 326 F.3d
1282 at 1285 (DC Cir. 2003) (finding no jurisdiction because ``so
general and vague a statement'' in a petition for rehearing fails to
meet the requirement in section 19(b) of the Natural Gas Act, which
requires that objections be ```specifically urged,''' quoting
Louisiana Interstate Gas Corp. v. FERC, 962 F.2d 37, 41 (DC Cir.
1992)); California Dep't of Water Resources v. FERC, 341 F.3d 906,
911 (9th Cir. 2003) (issue not preserved for review where petitioner
``raised the issue in a single sentence at the end of an unrelated
section of its request for rehearing, without citing the statutory
language it now urges [the court] to consider''), reh'g en banc
denied, 361 F.3d 517 (2004); California Dep't of Water v. FERC, 306
F.3d 1121, 1126 (DC Cir. 2002) (court dismisses petition for
judicial review because issue raised in a footnote ``does not
properly present, and thus does not preserve, the issue the
intervenors wish to argue''); and Coalition for the Fair and
Equitable Regulation of Docks on the Lake of the Ozarks v. FERC, 297
F.3d 771, 777 (8th Cir. 2002) (declining to find jurisdiction where
petitioner's ``brief does not show that it raised the * * *
arguments in any recognizable form''), reh'g en banc denied, 2002
U.S. App. LEXIS 21769 (8th Cir. Oct. 17, 2002), cert. denied, 538
U.S. 960 (2003).
---------------------------------------------------------------------------

    5. This final rule also amends the language in Rule 713 to account
for the now-eliminated requirement in Rule 203(a) to include a
``Statement of Issues'' section. Current Rule 713 states that requests
for rehearing must ``[c]onform to the requirements in Rule 203(a),
which are applicable to pleadings, including, but not limited to, the
requirement for a separate section entitled `Statement of Issues,'
listing each issue in a separately enumerated paragraph that includes
representative Commission and court precedent on which the party is
relying; and * * *.'' \5\ This section is being revised to state that
requests for rehearing must ``[c]onform to the requirements in Rule
203(a), which are applicable to pleadings, and, in addition, include a
separate section entitled `Statement of Issues,' listing each issue in
a separately enumerated paragraph that includes representative
Commission and court precedent on which the party is relying; any issue
not so listed will be deemed waived; and * * *.''
---------------------------------------------------------------------------

    \5\ 18 CFR 385.713(c)(2), as modified by Order No. 663, P 6.
---------------------------------------------------------------------------

    6. The rehearing rule at Sec.  385.713(c)(2) continues to specify
that issues not so raised will be deemed to have been waived. As noted
in Order No. 663 at P 7, this is consistent with existing Rule 2001,
which states that filings that fail to meet applicable statutes, rules
or orders may be rejected in full or all or part of the filing may be
stricken.\6\
---------------------------------------------------------------------------

    \6\ 18 CFR 385.2001(b)(2005).
---------------------------------------------------------------------------

    7. The revisions adopted in this rule are more appropriately
characterized as a clarification of the Commission's rules rather than
a change in Commission policy or a significant revision of the existing
rules of practice and procedure. Rule 713, prior to the enactment of
Order No. 663, required parties filing for rehearing to ``state
concisely the alleged error in the final decision or final order.''
However, Rule 713 was neither adhered to uniformly nor applied in
pleadings consistently. Therefore, we are requiring that all rehearing
requests include a separately designated section and an itemized and
enumerated Statement of Issues, which will help eliminate ambiguities
among parties, the Commission, and the reviewing courts, as discussed
above.
    8. The changes that are made in this rule eliminate one requirement
in Rule 203(a)(7) and make necessary amendments to Rule 713(c)(2) to
reflect the change in Rule 203(a)(7).

Information Collection Statement

    9. The Office of Management and Budget's (OMB's) regulations
require that OMB approve certain information collection requirements
imposed by agency rule. 5 CFR 1320.12 (2005). This Final Rule contains
no additional information reporting requirements, and is not subject to
OMB approval.

Environmental Analysis

    10. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\7\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. Included in the exclusion are rules that are clarifying,
corrective, or procedural that do not substantially change the effect
of the regulations being amended. This rule is procedural in nature
and, therefore, falls under this exception; consequently, no
environmental consideration is necessary.
---------------------------------------------------------------------------

    \7\ Regulations Implementing the National Environmental Policy
Act, Order No. 486, 52 FR 47897 (December 17, 1987), FERC Stats. &
Regs. Preambles 1986-1990 ] 30,783 (1987).
---------------------------------------------------------------------------

Regulatory Flexibility Act Certification

    11. The Regulatory Flexibility Act of 1980 (RFA) \8\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
The Commission is not required to make such analysis if a rule would
not have such an effect. The Commission certifies that this rule will
not have such an impact on small entities as it merely clarifies
existing requirements. An analysis under the RFA, therefore, is not
required.
---------------------------------------------------------------------------

    \8\ 5 U.S.C. 601-612 (1994).
---------------------------------------------------------------------------

Document Availability

    12. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through FERC's Home Page (http://www.ferc.gov) under ``What's

New'' and in FERC's Public Reference Room during normal business hours
(8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A,
Washington, DC 20426.
    13. From FERC's Home Page on the Internet, this information is
available in the Commission's document management system, eLibrary. The
full text of this document is available on eLibrary in PDF and
Microsoft Word format for viewing, printing, and/or downloading. To
access this document in eLibrary, type the docket number excluding the
last three digits of this document in the docket number field.
    14. User assistance is available for eLibrary and the FERC's Web
site during normal business hours. For assistance, please contact the
Commission's Online Support at 1-866-208-3673 (toll free) or 202-502-
6652 (e-mail at<EMAIL_ADDRESS>or the Public Reference
Room at<PHONE_NUMBER>, TTY<PHONE_NUMBER>. E-Mail the Public Reference
Room at<EMAIL_ADDRESS>
Effective Date

    15. These regulations are effective immediately upon publication in
the Federal Register. In accordance with 5 U.S.C. 553(d)(3), the
Commission finds that good cause exists to make this Final Rule
effective immediately upon publication. It concerns only a matter of
procedure eliminating a requirement affecting formatting of filings.
    16. The provisions of 5 U.S.C. 801 regarding Congressional review
of Final Rules does not apply to this Final Rule, because the rule
concerns agency procedure and practice and will not substantially
affect the rights of non-agency parties.
    17. The Commission is issuing this as a final rule without a period
for public comment. Under 5 U.S.C. 553(b), notice and comment
procedures are unnecessary where a rulemaking concerns only agency
procedure and practice, or where the agency finds that notice and
comment is unnecessary. This rule concerns only a clarification of a
matter of agency procedure and will not significantly affect regulated
entities or the general public.

List of Subjects in 18 CFR Part 385

    Administrative practice and procedure, Electric utilities,
Penalties, Pipelines, Reporting and recordkeeping requirements.

    By the Commission.
Magalie R. Salas,
Secretary.

0
In consideration of the foregoing, the Commission amends part 385,
Chapter I, Title 18, Code of Federal Regulations, as follows.

PART 385--RULES OF PRACTICE AND PROCEDURE

0
1. The authority citation for part 385 continues to read as follows:

    Authority: 5 U.S.C. 551-557; 15 U.S.C. 717-717z; 3301-3432; 16
U.S.C. 791a-825r; 2601-2645; 28 U.S.C. 2461; 31 U.S.C. 3701, 9701;
42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C. 1085 (1988).

0
2. Section 385.203 is amended by revising paragraph (a)(7) to read as
follows:

Sec.  385.203  Content of pleadings and tariff or rate filings (Rule
203).

    (a) * * *
    (7) The position taken by the participant filing any pleading, to
the extent known when the pleading is filed, and the basis in fact and
law for such position;
* * * * *

0
3. Section 385.713 is amended by revising paragraph (c)(2) to read as
follows:

Sec.  385.713  Request for rehearing (Rule 713).

* * * * *
    (c) * * *
    (2) Conform to the requirements in Rule 203(a), which are
applicable to pleadings, and, in addition, include a separate section
entitled ``Statement of Issues,'' listing each issue in a separately
enumerated paragraph that includes representative Commission and court
precedent on which the party is relying; any issue not so listed will
be deemed waived; and
* * * * *
[FR Doc. 06-2800 Filed 3-22-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 19, 2007 (Volume 72, Number 117)]
[Notices]
[Page 33792-33793]
[DOCID:fr19jn07-93]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55903; File No. SR-BSE-2007-24]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Allow NMS Cross Order Type To Be Sent to the Boston Equities Exchange

June 13, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 7, 2007, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
The Exchange has designated the proposed rule change as ``non-
controversial'' under Section 19(b)(3)(A)(iii) \3\ of the Act and Rule
19b-4(f)(6) thereunder,\4\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The BSE proposes amending the BSE Rules to allow the NMS Cross
Order type to be sent to the Boston Equities Exchange (``BeX''). The
text of the proposed rule change is available at BSE, the Commission's
Public Reference Room, and on the Exchange's Web site (http://www.bostonstock.com
).

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The BSE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to allow NMS Cross
Orders to be sent to BeX. An NMS Cross Order is an order that contains
an instruction to execute a cross transaction at a specific price and
an instruction to execute all displayed and undisplayed orders or
undisplayed portions of orders already in BeX at their limit prices (up
to a specified number of shares) against a specified party to allow the
cross transaction to occur and/or to route outbound orders to other
Trading Centers to the extent necessary to prevent an improper trade-
through.
    An NMS Cross may represent interest of one or more Members of the
Exchange but, to the extent that it represents interest of the Member
sending the order to BeX, the Member shall not be eligible to satisfy
existing

bids or offers in BeX at a price that is better than the cross price
(when a Member's customer is on the same side of the order as the
Member) and could only satisfy bid or offers in other markets at a
price that is better than the cross price if the cross is for at least
10,000 shares or has a value of at least $200,000 (a ``block size
order'') or is for the account of an institutional customer (as that
term is defined in Interpretation and Policy .03 of Chapter XXXVII,
Section 2(Q)) \5\ and the Member's customer has specifically agreed to
that outcome. Members must handle their customer limit orders with due
care so as to comply with Chapter II, Section 11 of the BSE Rules
prohibiting a Member from trading ahead of customer orders.
---------------------------------------------------------------------------

    \5\ Proposed Interpretation and Policy .03 of Chapter XXXVII,
Section 2(Q) defines the term ``institutional customer'' as ``the
account of: (a) A bank, savings and loan association, insurance
company or registered investment company; (b) an investment advisor
registered either with the Commission under Section 203 of the
Investment Advisers Act of 1940 or with a state securities
commission (or any agency office performing like functions); or (c)
any other entity (whether a natural person, corporation,
partnership, trust or otherwise) with total assets of at least $50
million.''
---------------------------------------------------------------------------

    The NMS Cross Order provides a Member with an efficient mechanism
to clear out orders in BeX that would otherwise have time or price
priority (and/or displayed bids or offers in other Trading Centers that
would otherwise have price priority) and then to effect a cross
transaction at a particular price. If an NMS Cross Order is sent with a
share size that is too small to satisfy orders in BeX or bids or offers
in other markets, as applicable, the order will be automatically
cancelled. The share size necessary to satisfy orders in BeX or bids
and offers in other markets is separate and distinct from the cross
quantity and the cross quantity may not be diminished in order to
supplement the share size intended to satisfy orders in BeX or bids and
offers in other markets. Once the satisfying execution has occurred
(or, for orders sent to other Trading Centers, those orders have been
sent), the cross will be executed at a price that is better than the
best bid or offer in BeX.
2. Statutory Basis
    The Exchange believes that the basis under the Act for this
proposed rule change is the requirement under Section 6(b)(5) \6\ that
an Exchange have rules that are designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days after the date of filing, or such shorter time as the Commission
may designate if consistent with the protection of investors and the
public interest, the proposed rule change has become effective pursuant
to Section 19(b)(3)(A) of the Act \7\ and subparagraph (f)(6) of Rule
19b-4 thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in the furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-BSE-2007-24 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BSE-2007-24. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of BSE. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-BSE-2007-24 and should be submitted on or before July 10, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-11744 Filed 6-18-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Proposed Rules]
[Pages 59900-59903]
[FR Doc No: 2021-23264]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0570; Project Identifier 2019-SW-091-AD]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM); reopening
of comment period.

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

SUMMARY: The FAA is revising a notice of proposed rulemaking (NPRM)
that applied to certain Leonardo S.p.a. Model AW169 helicopters. This
action revises the NPRM by requiring modification of certain pilot and
co-pilot yaw pedal assemblies with an improved design and re-
identification of the affected parts, as specified in a European Union
Aviation Safety Agency (EASA) airworthiness directive (AD), which is
proposed for incorporation by reference (IBR). The FAA is proposing
this AD to address the unsafe condition on these products. Since these
actions would impose an additional burden over those in the NPRM, the
agency is requesting comments on this SNPRM.

DATES: The comment period for the NPRM published in the Federal
Register on July 28, 2021 (86 FR 40371), is reopened.
    The FAA must receive comments on this SNPRM by December 13, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For EASA material that is proposed for IBR in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; internet www.easa.europa.eu. You
may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view the EASA material at the

FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood
Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the
availability of the EASA material at the FAA, call<PHONE_NUMBER>. The
EASA material is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0570.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0570; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains the NPRM, this SNPRM,
the EASA AD, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Kristi Bradley, Program Manager, COS
Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0570; Project Identifier
2019-SW-091-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Kristi Bradley, Program Manager, COS Program Management Section,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected]. Any commentary that the FAA receives
that is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Background

    The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to certain Leonardo S.p.a. Model AW169 helicopters. The
NPRM published in the Federal Register on July 28, 2021 (86 FR 40371).
In the NPRM, the FAA proposed to require modification of the pilot and
co-pilot yaw pedal assemblies. The NPRM was prompted by EASA AD 2019-
0252, dated October 10, 2019 (EASA AD 2019-0252), issued by EASA, which
is the Technical Agent for the Member States of the European Union, to
correct an unsafe condition for Leonardo S.p.a. (formerly Finmeccanica
S.p.A and AgustaWestland S.p.A) Model AW169 helicopters, all serial
numbers. EASA advised that there was a report of a broken adjustable
device that is part of the pilot and co-pilot yaw pedal assemblies.
This condition, if not addressed, could result in failure of a yaw
pedal adjuster, which could result in reduced yaw control of the
helicopter.
    Accordingly, EASA AD 2019-0252 required modification (rework) of
the affected pilot and co-pilot assemblies and re-identification of
each affected part after it has been modified. The modification
included the installation of additional end stroke stops on the pilot
and co-pilot pedal assemblies. EASA considered EASA AD 2019-0252 an
interim action and stated that further EASA AD action may follow.

Actions Since the NPRM Was Issued

    Since the NPRM was issued, EASA issued AD 2021-0199, dated August
27, 2021 (EASA AD 2021-0199), which supersedes EASA AD 2019-0252. EASA
advises that three additional events have been reported where the
universal joint of the adjusting mechanism on the yaw pedals failed.
Prompted by these findings, Leonardo S.p.a. developed a new
modification that introduces upgraded pilot and co-pilot pedal
assemblies with an improved design, which removes the failure modes.
Accordingly, EASA AD 2021-0199 requires modification (rework) of the
affected pilot and co-pilot assemblies and re-identification of each
affected part after it has been modified. The modification includes
replacing the pedal main support assembly, adjuster screw assembly,
knob assembly, and spring pin, and removing the additional end stroke
stops that were installed on the pilot and co-pilot pedal assemblies
using the modification specified in EASA AD 2019-0252. EASA AD 2021-
0199 also provides an option to replace an affected part with a non-
affected part instead of doing the modification.
    In addition, the FAA revised the applicability of this proposed AD
from Leonardo S.p.a. Model AW169 helicopters with an affected part
installed (as specified in the NPRM), to all Leonardo S.p.a. Model
AW169 helicopters. This revised applicability matches EASA AD 2021-
0199.

Comments

    The FAA gave the public the opportunity to participate in
developing this proposed AD. The FAA received no comments on the NPRM
or on the determination of the cost.

FAA's Determination

    This helicopter has been approved by EASA and is approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that
the unsafe condition described previously is likely to exist or develop
on other helicopters of the same type design. Certain changes described
above expand the scope of the NPRM. As a result, it is necessary to
reopen the comment period to provide additional opportunity for the
public to comment on this SNPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0199 requires modification of the affected pilot and
co-pilot assemblies and re-identification of each affected part after
it has been modified. EASA AD 2021-0199 also

provides an option to replace an affected part with a non-affected part
instead of doing the modification. EASA AD 2021-0199 also prohibits the
installation of affected parts.
    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.

Proposed AD Requirements in This SNPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0199, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use certain civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2021-0199 will be incorporated by reference in the FAA final
rule. This proposed AD would, therefore, require compliance with EASA
AD 2021-0199 in its entirety, through that incorporation, except for
any differences identified as exceptions in the regulatory text of this
proposed AD. Using common terms that are the same as the heading of a
particular section in EASA AD 2021-0199 does not mean that operators
need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0199. Service information specified in EASA AD 2021-0199 that is
required for compliance with it will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0570 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 10 helicopters of U.S. Registry. The FAA estimates the following
costs to comply with this proposed AD.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Modify and re-identify affected parts.  25 work-hours x $85 per               $0          $2,125         $21,250
                                         hour = $2,125.
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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 Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

Leonardo S.p.a.: Docket No. FAA-2021-0570; Project Identifier 2019-
SW-091-AD.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by December 13, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Leonardo S.p.a. Model AW169 helicopters,
certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6700, Rotorcraft
Flight Control.

(e) Unsafe Condition

    This AD was prompted by a report of a broken adjustable device
that is part of the pilot and co-pilot yaw pedal assemblies. The FAA
is issuing this AD to address failure of a yaw pedal adjuster, which
could result in reduced yaw control of the helicopter.

(f) Compliance

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

(g) Requirements

    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
2021-0199, dated August 27, 2021 (EASA AD 2021-0199).

(h) Exceptions to EASA AD 2021-0199

    (1) Where EASA AD 2021-0199 refers to flight hours, this AD
requires using hours time-in-service.
    (2) Where EASA AD 2021-0199 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) Where the service information referenced in EASA AD 2021-
0199 specifies discarding certain parts, this AD requires removing
those parts from service.
    (4) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2021-0199.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0199
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) 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 manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (l)(2) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    (1) For EASA AD 2021-0199, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may view this
material at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For
information on the availability of this material at the FAA, call
(817) 222-5110. This material may be found in the AD docket at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0570.
    (2) For more information about this AD, contact Kristi Bradley,
Program Manager, COS Program Management Section, Operational Safety
Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].

    Issued on October 20, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-23264 Filed 10-28-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47765-47766]
[FR Doc No: 2022-16686]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0297]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Production, Storage
and Transportation of Shell Eggs (Preventing Salmonella Enteritidis
(SE))

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 6, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0660. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Production, Storage and Transportation of Shell Eggs (Preventing
Salmonella Enteritidis (SE))

OMB Control Number 0910-0660--Extension--21 CFR 118.10 and 118.11

    This information collection supports Agency regulations in part 118
(21 CFR part 118), Production, Storage, and Transportation of Shell
Eggs, and Form FDA 3733, Shell Egg Producer Registration Form. The
Public Health Service Act (PHS Act) (42 U.S.C. 264) authorizes the
Secretary of Health and Human Services to make and enforce such
regulations as ``are necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the States . . . or from one State . . . into any other State''
(section 361(a) of the PHS Act (42 U.S.C. 264(a))). This authority has
been delegated to the Commissioner of Food and Drugs. Under section
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(4)), a food is adulterated if it is prepared, packed, or
held under insanitary conditions whereby it may have been contaminated
with filth or rendered injurious to health. Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for
the efficient enforcement of the FD&C Act.
    Under part 118, shell egg producers are required to implement
measures to prevent SE from contaminating eggs on the farm and from
further growth during storage and transportation. Shell egg producers
also are required to maintain records concerning their compliance with
part 118 and to register with FDA. As described in more detail about
each information collection provision of part 118, each farm site with
3,000 or more egg laying hens that sells raw shell eggs to the table
egg market, other than directly to the consumer, must refrigerate,
register, and keep certain records. Farms that do not send all their
eggs to treatment are also required to have an SE prevention plan and
to test for SE.
    Section 118.10 of FDA's regulations requires recordkeeping for all
measures the farm takes to prevent SE in its flocks. Since many
existing farms participate in voluntary egg quality assurance programs,
those respondents may not have to collect any additional information.
Records are maintained on file at each farm site and examined there
periodically by FDA inspectors.
    Section 118.10 also requires each farm site with 3,000 or more egg
laying hens that sells raw shell eggs to the table egg market, other
than directly to the consumer, and does not have all of the shell eggs
treated, to design and implement an SE prevention plan.
    Section 118.10 requires recordkeeping for each of the provisions
included in the plan and for plan review and modifications if
corrective actions are taken.
    Finally, Sec.  118.11 of FDA's regulations requires that each farm
covered by Sec.  118.1(a) register with FDA using Form FDA 3733. The
term ``Form FDA 3733'' refers to both the paper version of the form and
the electronic system known as the Shell Egg Producer Registration
Module, which is available at https://www.access.fda.gov. We strongly
encourage electronic registration because it is faster and more
convenient. The system can accept electronic registrations 24 hours a
day, 7 days a week. A registering shell egg producer receives
confirmation of electronic registration instantaneously once all the
required fields on the registration screen are completed. However,
paper registrations will also be accepted. Form FDA 3733 is available
for download for registration by mail, fax, or CD-ROM. For more
information, we invite you to visit our websites at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration and http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm.
    Recordkeeping and registration are necessary for the success of the
SE prevention measures. Written SE prevention plans and records of
actions taken due to each provision are essential for farms to
implement SE prevention plans effectively. Further, they are essential
for us to be able to determine compliance. Information provided under
these regulations helps us to quickly notify the facilities that might
be affected by a deliberate or accidental contamination of the food
supply. In addition, data collected through registration is used to
support our enforcement activities.
    Description of Respondents: Respondents to this information
collection include farm sites with 3,000 or more egg laying hens that
sell raw eggs to the table egg market, other than directly to the
consumer.
    In the Federal Register of January 19, 2022 (87 FR 2797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received, however only one
was responsive to the four information collection topics solicited.
    The comment suggested that farms could save money by pooling
samples while conducting environmental testing, proffering a 2015
research article. FDA reviewed the 2015 research article by Kinde et
al. and had additional questions about the equivalency of pooled versus
non-pooled samples. This

led to a subsequent 2020 study conducted and published by Jones et al.,
which found that analysis of pooled samples was not equivalent to that
of single samples. In environmental samples, the level of background
microflora plays a role in the ability to detect SE, if present. When
samples are pooled, the amount of background microflora is amplified,
potentially causing the inability to detect SE by masking its presence.
This is further exacerbated based on the number of pooled samples
(e.g., two vs. four samples per collection bag) and could result in
false negative test results. After consideration of the science, FDA
determined that at this time, there is not sufficient data to consider
pooled samples equivalent to single samples, as required by the
reference methods cited in Sec.  118.8. While we understand cost
considerations are important, the primary concern should always be the
ability to detect SE if it is present.
    The comment also suggested adjusting the egg testing protocol to
two 1,000-egg samples instead of four 1,000-egg samples. Testing four
1,000-egg samples over an 8-week period results in approximately a 95
percent probability that a positive egg will be detected from a flock
that is producing SE-contaminated eggs with a prevalence of 1 in 1,400.
Testing fewer than 4,000 eggs over a period of 8 weeks, as required by
Sec.  118.7, would result in less than a 95 percent probability that a
positive egg would be detected from a flock that is producing SE-
contaminated eggs at that rate.
    We find that the required testing established under 21 CFR 118.7
and 118.8 best protects the public health and that relaxing the current
testing requirements, whether or not in an effort to reduce costs,
would not provide the same level of protection necessary to ensure the
public health.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                     Number of       Number of
    Activity; 21 CFR section       recordkeepers    records per    Total annual   Average burden per     Total
                                        \2\        recordkeeper       records        recordkeeping       hours
----------------------------------------------------------------------------------------------------------------
Refrigeration Records; Sec.                2,600              52         135,200  0.5 (30 minutes)..      67,600
 118.10(a)(3)(iv).
Testing, Diversion, and                      343              52          17,836  0.5 (30 minutes)..       8,918
 Treatment Records; Sec.
 118.10(a)(3)(v) through (viii)
 (positive) \3\.
Egg Testing; Sec.                            331               7           2,317  8.3...............      19,231
 118.10(a)(3)(vii).
Environmental Testing; Sec.                6,308              23         145,084  0.25 (15 minutes).      36,271
 118.10(a)(3)(v) \3\.
Testing, Diversion, and                    5,965               1           5,965  0.5 (30 minutes)..       2,983
 Treatment Records; Sec.
 118.10(a)(3)(v) through (viii)
 (negative) \3\.
Prevention Plan Review and                   331               1             331  10................       3,310
 Modifications; Sec.
 118.10(a)(4).
Chick and Pullet Procurement               4,731               1           4,731  0.5 (30 minutes)..       2,366
 Records; Sec.   118.10(a)(2).
Rodent and Other Pest Control;             9,462              52         492,024  0.5 (30 minutes)..     246,012
 Sec.   118.10(a)(3)(ii), and
 Biosecurity Records, Sec.
 118.10(a)(3)(i).
Prevention Plan Design; Sec.                 350               1             350  20................       7,000
 118.10(a)(1).
Cleaning and Disinfection                    331               1             331  0.5 (30 minutes)..         166
 Records; Sec.
 118.10(a)(3)(iii).
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..................     393,857
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Some records are kept on a by-farm basis and others are kept on a by-house basis.
\3\ Calculations include requirements for pullet and layer houses.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
          Activity; 21 CFR section                         Form                  Number of     responses per   Total annual   Average burden     Total
                                                                                respondents     respondent       responses     per response      hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates; Sec.   118.11.....  FDA 3733 \2\..................             350               1             350             2.3         805
Cancellations; Sec.   118.11................  FDA 3733......................              30               1              30               1          30
                                                                             ---------------------------------------------------------------------------
    Total...................................  ..............................  ..............  ..............  ..............  ..............         835
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration
  Module, which is available at http://www.access.fda.gov per Sec.   118.11(b)(1).

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimates for the recordkeeping burden and the reporting
burden are based on our experience with similar recordkeeping
activities and the number of registrations and cancellations received
in the past 3 years.

    Dated: July 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16686 Filed 8-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8722]
[DOCID:fr27fe07-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-35-000]

Key-Span Ravenswood, LLC, Complainant v. New York Independent
System Operator, Inc., Respondent; Notice of Complaint

February 21, 2007.
    Take notice that on February 15, 2007, Key-Span Ravenswood, LLC
(Ravenswood) filed a formal complaint against the New York Independent
System Operator, Inc. (NYISO) pursuant to Federal Power Act sections
206 and 306, alleging that, under section 5.4 of the NYISO's Services
Tariff, Ravenswood is due its full incremental operating costs,
including lost opportunity costs, incurred in all hours since May 1,
2006, when Ravenswood responded to fuel security dispatch instructions
to switch from natural gas to more expensive fuel oil under Rule I-R3
of the New York State Reliability Council.
    Ravenswood certifies that copies of the complaint were served on
the contacts for NYISO as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 19, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-3345 Filed 2-26-07; 8:45 am]

BILLING CODE 6717-01-P