[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18144-18146]
[FR Doc No: 2023-06292]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1149]

Transition Plan for Medical Devices Issued Emergency Use
Authorizations Related to Coronavirus Disease 2019 (COVID-19); Guidance
for Industry, Other Stakeholders, and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Transition Plan for
Medical Devices Issued Emergency Use Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID-19).'' FDA recognizes that it will take
time for device manufacturers, device distributors, healthcare
facilities, healthcare providers, patients, consumers, and FDA to
adjust from policies adopted and operations implemented during the
COVID-19 pandemic to ``normal operations.'' To provide a clear policy
for all stakeholders and FDA staff, the Agency is issuing this guidance
to describe FDA's general recommendations for this transition process
with respect to devices issued EUAs related to COVID-19, including
recommendations regarding submitting a marketing submission, as
applicable, and taking other actions with respect to these devices.

DATES: The announcement of the guidance is published in the Federal
Register on March 27, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-1149 for ``Transition Plan for Medical Devices Issued
Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019
(COVID-19).'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Transition Plan for Medical Devices Issued Emergency Use
Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)''
to the Office of Policy, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 240-
402-9677.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, the Secretary of Health and Human Services
(the Secretary) issued a declaration of a public health emergency (PHE)
related to COVID-19 in accordance with section 319 of the Public Health
Service Act (section 319 PHE) (42 U.S.C. 247d) and mobilized the
Operating Divisions of the Department of Health and Human Services
(HHS).\1\ Pursuant to section 564 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), on February 4, 2020, the
Secretary determined that there is a PHE that has significant potential
to affect national security or the health and security of U.S. citizens
living abroad, and that involves the SARS-CoV-2 virus that causes
COVID-19. On the basis of such determination, the Secretary declared on
that same day, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
the SARS-CoV-2 virus that causes COVID-19 (85 FR 7316). Based on the
February 4, 2020, determination, the Secretary issued two more
declarations justifying emergency uses related to devices: on March 2,
2020, for certain personal respiratory protective devices (85 FR
13907), and on March 24, 2020, for devices, including alternative
products used as devices (85 FR 17335). On March 15, 2023, the
Secretary amended the February 4, 2020 determination to recognize the
fact that there is ``a public health emergency, or a significant
potential for a public health emergency, that affects, or has a
significant potential to affect, national security or the health and
security of United States citizens living abroad . . .'' and that
involves the SARS-CoV-2 virus that causes COVID-19 (emphasis added) (88
FR 16644).
---------------------------------------------------------------------------

    \1\ Secretary of HHS, Determination that a Public Health
Emergency Exists (originally issued on January 31, 2020, and
subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. On February 9, 2023, the
Secretary renewed the section 319 PHE declaration related to COVID-
19, effective February 11, 2023. The section 319 PHE declaration
related to COVID-19 is anticipated to expire at the end of the day
on May 11, 2023. See the HHS ``Fact Sheet: COVID-19 Public Health
Emergency Transition Roadmap,'' (February 9, 2023), available at
https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html.
---------------------------------------------------------------------------

    Section 564 of the FD&C Act authorizes FDA, after the Secretary has
made a declaration of emergency or threat justifying authorization of
emergency use, to authorize the emergency use of an unapproved product
or an unapproved use of an approved product for certain emergency
circumstances. FDA may issue an EUA to allow a product to be used to
diagnose, treat, or prevent a serious or life-threatening disease or
condition referenced in the EUA declaration, when the statutory
criteria are met, including FDA's determination that, based on the
totality of scientific evidence, the product may be effective for such
use, the known and potential benefits outweigh the known and potential
risks for such use, and that there are no adequate, approved, and
available alternatives.
    An EUA issued under section 564 of the FD&C Act remains in effect
for the duration of the relevant EUA declaration, unless the EUA is
revoked because the criteria for issuance are no longer met or
revocation is appropriate to protect public health or safety (see
section 564(f) through (g) of the FD&C Act).
    Given the magnitude of the response to the COVID-19 pandemic,
including the number of devices issued EUAs, FDA recognizes that
stakeholders may need time to adjust after the termination of the
device EUA declarations to help to ensure an orderly and transparent
transition to ``normal operations.'' The Agency is issuing this
guidance to describe FDA's general recommendations for this transition
process with respect to devices issued EUAs related to COVID-19,
including recommendations regarding submitting a marketing submission,
as applicable, and taking other actions with respect to these devices.
FDA is concurrently issuing a companion transition guidance to describe
FDA's recommendations for devices that fall within certain enforcement
policies issued during the section 319 PHE related to COVID-19.
    This guidance applies to devices that have been issued an EUA under
section 564 of the FD&C Act on the basis of a device EUA declaration
related to COVID-19. This guidance does not apply to devices for which
FDA has revoked the EUA under section 564(g)(2)(B) through (C) of the
FD&C Act because the criteria under section 564(c) of the FD&C Act were
no longer met or because other circumstances made such revocation
appropriate to protect the public health or safety.
    HHS intends to publish the advance notice of termination of each
EUA declaration pertaining to devices in the Federal Register 180 days
before the day on which the EUA declaration is terminated. The advance
notice of termination of each device EUA declaration may occur
simultaneously or at different times, depending on whether the
circumstances underlying such declarations continue to exist (section
564(b)(2)(A) of the FD&C Act).
    A notice of availability of the draft guidance appeared in the
Federal Register of December 23, 2021 (86 FR 72978). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including revising the recommendation for interim
labeling during the time when the device EUA declaration has been
terminated and a manufacturer's marketing submission for a device is
under FDA review, providing clarity on recommendations regarding
physical and/or electronic copies of updated labeling, and adding
clarifications regarding use of real-world evidence in marketing
submissions, interactions with FDA, collaboration with stakeholders on
the transition process, in vitro diagnostics, and example scenarios.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the ``Transition Plan for Medical Devices
Issued Emergency Use Authorizations (EUAs) Related to Coronavirus
Disease 2019 (COVID-19).'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Transition Plan for Medical Devices
Issued Emergency Use Authorizations (EUAs) Related to Coronavirus
Disease 2019 (COVID-19)'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00020042 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA). The collections of information in the following FDA
regulations and guidance have been approved by OMB as listed in the
table below.
    This guidance also contains new collections of information not
approved under a current collection. These new collections of
information have been granted a PHE waiver from the PRA by HHS on March
19, 2020, under section 319(f) of the PHS Act. Information concerning
the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

----------------------------------------------------------------------------------------------------------------
                                        Another guidance referenced in    OMB control    New collection covered
 CFR cite referenced in this guidance            this guidance              No(s).          by PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
                                        ``Emergency Use Authorization        0910-0595
                                         of Medical Products and
                                         Related Authorities; Guidance
                                         for Industry and Other
                                         Stakeholders''.
                                        ``Requests for Feedback and          0910-0756
                                         Meetings for Medical Device
                                         Submissions: The Q-Submission
                                         Program Guidance for Industry
                                         and Food and Drug
                                         Administration Staff''.
                                        ``Administrative Procedures          0910-0607
                                         for CLIA Categorization'' and
                                         ``Recommendations for
                                         Clinical Laboratory
                                         Improvement Amendments of
                                         1988 (CLIA) Waiver
                                         Applications for
                                         Manufacturers of In Vitro
                                         Diagnostic Devices--Guidance
                                         for Industry and FDA Staff''.
800, 801, and 809.....................  ..............................       0910-0485
803...................................  ..............................       0910-0437
806...................................  ..............................       0910-0359
807, subparts A through D.............  ..............................       0910-0625
807, subpart E........................  ..............................       0910-0120
812...................................  ..............................       0910-0078
814, subparts A through E.............  ..............................       0910-0231
814, subpart H........................  ..............................       0910-0332
820...................................  ..............................       0910-0073
830 and 801.20........................  ..............................       0910-0720
860, subpart D........................  ..............................       0910-0844
                                                                                Notification of Intent.
                                                                                Transition
                                                                                Implementation Plan.
                                                                                Labeling Mitigation for
                                                                                Certain Reusable
                                                                                Devices.
----------------------------------------------------------------------------------------------------------------

    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06292 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P


Personal Communication with KCMA. 2010. Conversation between Richard
Titus (Kitchen Cabinet Manufacturers Association) and Abt Associates
Inc. regarding written questions about FSCWPA Impacts. October 28, 2010.
 Matt LaPenta spoke with Bill Perdue on 11.02.2010.

Number of Fabricators

What percentage of furniture manufacturers would you estimate use
composite wood products (hardwood plywood, particleboard, or medium
density fiberboard) in their products?

Hundreds of fabricators worldwide.  There are many offshore fabricators.
 90% of wood-based furniture manufacturers use composite wood products.
Wood based furniture is the lion’s share of the market.  For Home
furnishings 80% of furniture is wood based.

Of these manufacturers, what percentage would you estimate produce at
least some product lines that are CARB compliant because they use CARB
certified panels or component parts and follow the CARB recordkeeping
and labeling requirements?

All are complying with CARB.  All are following recordkeeping and
labeling requirements.  This is true for AHFA members and non-members.
Sources of non-compliant product are not available.

Do the manufacturers that are producing CARB compliant product lines
also carry product lines for sale outside of California that are not
CARB compliant?  If, so what percentage of production volume would you
estimate are product lines that are not compliant with CARB because they
do not use CARB certified panels or component parts or do not follow the
CARB recordkeeping and labeling requirements?

No – separate inventory would be too difficult.

Impact of Labeling Requirements

A national regulation of composite wood products could potentially
require manufacturers that use composite wood materials to put a label
on every separate item that gets produced and shipped out.  Given this,
could you estimate the average number of labels that would be needed
annually for each manufacturer that uses composite wood materials?

All products have a manufacturing label with product number and SKU.
CARB compliance is also indicated on this label.  This system works well
because manufacturers use the existing labels. Labels are on the boxes
and the products.  There are millions of labels.

If labels were required for each shipment of products instead of each
individual item, about how may items would be included in a typical
shipment?

This would not work for furniture.  Lot labeling would make it harder to
track it back to the board manufacturer.  AHFA says lot labeling of
panels makes it harder for the fabricators because it makes their
recordkeeping more difficult. .

Number of Wood Veneer “Laminator Product”  Manufacturers

The recent federal legislation uses the term laminated product to mean a
finished good (such as a custom panel, cabinet, window, door, or piece
of furniture) that is produced by affixing a wood veneer to a purchased
platform.  How many of your members would you say produce such laminated
products by affixing wood veneer themselves?  Please do not include
other types of laminates (such as high pressure laminates, thermally
fused papers, vinyl films, decorative foils, or polypropylene films) in
your answer.

All domestic manufacturers do this.  There are about 250 domestic
manufacturers who are laminators.

For those manufacturers that would be classified as wood veneer
laminators, how common is it for these manufacturers to also fabricate
products using purchased panels that were already finished with a wood
veneer or other decorative finish?

Common. Laminators would also use purchased panels.

What percentage of the production of wood veneer laminated products are
produced using formaldehyde-based resins to affix wood veneers to
purchased platforms?

Some use cold press PVA.  Typically use UF.

If wood veneer laminators using UF resins were to switch to a lower
emission resin, what would be the likely resin choice?

Not sure. Dictated by market.

Of those wood veneer laminators that use no-added formaldehyde resins,
what are the most common adhesives used?

Not sure. Dictated by market.

If wood veneer laminators were subject to the same third party testing
requirements as CARB, about how many different product types would need
to be third party certified for a typical manufacturer?

Not sure.  Would be a burden but not as many products as a custom panel
manufacturer.

General comments

Worlds largest home furniture association

450 members

Represents all levels of supply chain

International and domestic members

Was @ table with CARB

Was active with Klobuchar

Has engaged with EPA

Performance questions associated with CARB 2 resins.  More boards seem
to have mold problems.


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Proposed Rules]
[Pages 69568-69569]
[FR Doc No: 2012-28131]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2012-1236; Notice No. 25-12-14-SC]

Special Conditions: Bombardier Aerospace, Model BD-500-1A10 and
BD-500-1A11 Airplanes; Sidestick Controllers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed special conditions.

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

SUMMARY: This action proposes special conditions for the Bombardier
Aerospace Model BD-500-1A10 and BD-500-1A11 airplanes. These airplanes
will have a novel or unusual design feature, specifically sidestick
controllers designed to be operated with only one hand. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These proposed special conditions
contain the additional safety standards that the Administrator
considers necessary to establish a level of safety equivalent to that
established by the existing airworthiness standards.

DATES: Send your comments on or before January 4, 2013.

ADDRESSES: Send comments identified by docket number [FAA-2012-1236]
using any of the following methods:
     Federal eRegulations 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 8 a.m. and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    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: Todd Martin, FAA, Airframe and Cabin
Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive on or before the closing
date for comments. We may change these special conditions based on the
comments we receive.

Background

    On December 10, 2009, Bombardier Aerospace applied for a type
certificate for their new Model BD-500-1A10 and BD-500-1A11 airplanes.
The Model BD-500-1A10 and BD-500-1A11 airplanes are swept-wing
monoplanes with pressurized cabins, and they share an identical
supplier base and significant common design elements. The fuselages are
aluminum alloy material, blended double-bubble fuselages, sized for
nominal five-abreast seating. Each airplane's powerplant includes two
under-wing Pratt and Whitney PW1524G ultra-high bypass, geared turbofan
engines. The flight controls are fly-by-wire flight with two passive/
uncoupled sidesticks. Avionics include five landscape primary cockpit
displays. The dimension of the aircraft encompasses a wingspan of 115
feet; height of 37.75 feet; and length of 114.75 feet for the Model BD-
500-1A10 and length of 127 feet for the Model BD-500-1A11. Passenger
capacity is designated as 110 for the Model BD-500-1A10 and 125 for the
Model BD-500-1A11. Maximum takeoff weight is 131,000 pounds for the
Model BD-500-1A10 and 144,000 pounds for the Model BD-500-1A11. Maximum
takeoff thrust is 21,000 pounds for the Model BD-500-1A10 and 23,300
pounds for the Model BD-500-1A11. The range is 5,463 kilometres for
both model airplanes. The maximum operating altitude is 41,000 feet for
both model airplanes.
    Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes will be
equipped with a sidestick controller instead of a conventional control
column and wheel. This kind of controller is designed for only one-hand
operation.
    The requirement of Title 14, Code of Federal Regulations (14 CFR
25.397(c)), which defines limit pilot forces and torques for
conventional wheel or stick controls, is not adequate for a sidestick
controller. A special condition is necessary to specify the appropriate
loading conditions for this kind of controller.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, Bombardier Aerospace must
show that the Model BD-500-1A10 and BD-500-1A11 airplanes meet the
applicable provisions of part 25, as amended by Amendments 25-1 through
25-129 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards

for the Bombardier Aerospace Model BD-500-1A10 and BD-500-1A11
airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Bombardier Aerospace Model BD-500-1A10 and BD-500-1A11
airplanes must comply with the fuel vent and exhaust emission
requirements of 14 CFR part 34 and the noise certification requirements
of 14 CFR part 36 and the FAA must issue a finding of regulatory
adequacy under Sec.  611 of Public Law 92-574, the ``Noise Control Act
of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Bombardier Aerospace Model BD-500-1A10 and BD-500-1A11
airplanes will incorporate the following novel or unusual design
feature: A sidestick controller instead of a conventional control
column and wheel. This kind of controller is designed for one-hand
operation.

Discussion

    The Bombardier Aerospace Model BD-500-1A10 and BD-500-1A11
airplanes are equipped with a sidestick controller instead of a
conventional wheel or control stick. This kind of controller is
designed to be operated using only one hand. The requirement of 14 CFR
25.397(c), which defines limit pilot forces and torques for
conventional wheel or stick controls, is not adequate for a sidestick
controller, because pilot forces are applied to sidestick controllers
with only the wrist, not arms. A special condition is necessary to
specify the appropriate loading conditions for a sidestick controller.
These proposed special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

Applicability

    As discussed above, these special conditions are applicable to the
Bombardier Aerospace Model BD-500-1A10 and BD-500-1A11 airplanes.
Should Bombardier Aerospace apply at a later date for a change to the
type certificate to include another model incorporating the same novel
or unusual design feature, the special conditions would apply to that
model as well.

Conclusion

    This action affects only certain novel or unusual design features
on Bombardier Aerospace Model BD-500-1A10 and BD-500-1A11 airplanes. It
is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the
following special conditions as part of the type certification basis
for Model BD-500-1A10 and BD-500-1A11 airplanes by Bombardier
Aerospace:

Limit Pilot Forces for Sidestick Control

    In lieu of the pilot forces specified in Sec.  25.397(c), for the
Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes equipped with
sidestick controls designed for forces to be applied by one wrist and
not arms, the limit pilot forces are as follows:
    1. For all components between and including the handle and its
control stops.

------------------------------------------------------------------------
                   Pitch                                Roll
------------------------------------------------------------------------
Nose up 200 pounds force (lbf)............  Nose Left 100 lbf.
Nose down 200 lbf.........................  Nose Right 100 lbf.
------------------------------------------------------------------------

    2. For all other components of the sidestick control assembly,
excluding the internal components of the electrical sensor assemblies,
to avoid damage as a result of an in-flight jam.

------------------------------------------------------------------------
                   Pitch                                Roll
------------------------------------------------------------------------
Nose up 125 lbf...........................  Nose Left 50 lbf.
Nose down 125 lbf.........................  Nose Right 50 lbf.
------------------------------------------------------------------------

    Issued in Renton, Washington, on November 14, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-28131 Filed 11-19-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 134 (Thursday, July 14, 2022)]
[Rules and Regulations]
[Pages 42068-42070]
[FR Doc No: 2022-14970]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0507; Project Identifier MCAI-2021-01372-T;
Amendment 39-22114; AD 2022-14-09]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Support and Services (Formerly
Known as Saab AB, Saab Aeronautics) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Saab AB, Support and Services Model 340A (SAAB/SF340A) and SAAB
340B airplanes. This AD was prompted by a report that there is no
evidence that post-machining stress relief or de-embrittlement post-
cadmium plating treatments were performed on certain torque arm center
pins. This AD requires replacing each affected torque arm center pin on
the main landing gear (MLG), as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. This AD
also prohibits the installation of affected parts. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective August 18, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 18,
2022.

ADDRESSES: For material incorporated by reference (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 this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2022-0507.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0507; 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.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation Branch,
2200 South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0273, dated December 8, 2021
(EASA AD 2021-0273) (also referred to as the MCAI), to correct an
unsafe condition for certain Saab AB, Support and Services Model 340A
(SAAB/SF340A) and SAAB 340B airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Saab AB,
Support and Services Model 340A (SAAB/SF340A) and SAAB 340B airplanes.
The NPRM published in the Federal Register on May 6, 2022 (87 FR
27035). The NPRM was prompted by a report that there is no evidence
that post-machining stress relief or de-embrittlement post-cadmium
plating treatments were performed on certain torque arm center pins.
The NPRM proposed to require replacing each affected torque arm center
pin on the MLG, as specified in EASA AD 2021-0273. The NPRM also
proposed to prohibit the installation of affected parts.
    The FAA is issuing this AD to address untreated torque arm center
pins installed on any MLG, which, if not corrected, could lead to
failure of the torque arm center pin and free swinging of the MLG,
possibly resulting in loss of control of the airplane on ground, or
loss of the MLG hydraulic braking function. See the MCAI for additional
background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
requires adopting this AD as proposed. Except for minor editorial
changes, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator. Accordingly,
the FAA is issuing this AD to address the unsafe condition on these
products.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0273 specifies procedures for replacing each affected
torque arm center pin on the MLG. EASA AD 2021-0273 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.

Costs of Compliance

    The FAA estimates that this AD affects 43 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.
                          Labor cost                              Parts cost        product        operators *
----------------------------------------------------------------------------------------------------------------
8 work-hours x $85 per hour = $680...........................          $2,839           $3,519         $151,317
----------------------------------------------------------------------------------------------------------------
* According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby
  reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected
  individuals. As a result, the FAA has included all known costs in the cost estimate.

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:

2022-14-09 Saab AB, Support and Services (Formerly Known as Saab AB,
Saab Aeronautics): Amendment 39-22114; Docket No. FAA-2022-0507;
Project Identifier MCAI-2021-01372-T.

(a) Effective Date

    This airworthiness directive (AD) is effective August 18, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Saab AB, Support and Services Model 340A
(SAAB/SF340A) and SAAB 340B airplanes, certificated in any category,
as identified in European Union Aviation Safety Agency (EASA) AD
2021-0273, dated December 8, 2021 (EASA AD 2021-0273).

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Unsafe Condition

    This AD was prompted by a report that there is no evidence that
post-machining stress relief or de-embrittlement post-cadmium
plating treatments were performed on certain torque arm center pins.
The FAA is issuing this AD to address untreated torque arm center
pins installed on any main landing gear (MLG), which, if not
corrected, could lead to failure of the torque arm center pin and
free swinging of the MLG, possibly resulting in loss of control of
the airplane on ground, or loss of the MLG hydraulic braking
function.

(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, EASA AD 2021-0273.

(h) Exceptions to EASA AD 2021-0273

    (1) Where EASA AD 2021-0273 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2021-0273 does not apply
to this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j) of this
AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Saab AB,
Support and Services' EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(j) Related Information

    For more information about this AD, contact Shahram Daneshmandi,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<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 this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0273,
dated December 8, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0273, 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
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material 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: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 27, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-14970 Filed 7-13-22; 8:45 am]
BILLING CODE 4910-13-P


                      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                          SECTOR POLICIES AND PROGRAMS DIVISION
                       OFFICE OF AIR QUALITY PLANNING AND STANDARDS
                               OFFICE OF AIR AND RADIATION

December 14, 2011

MEMORANDUM

SUBJECT:	Meeting notes for the September 29, 2011 meeting with AF&PA

FROM:	Kelley Spence
      John Bradfield

TO:		Docket EPA-HQ-OAR-2007-0544

This memorandum summarizes the meeting between The American Forest and Paper Association (AF&PA) and the EPA on September 29, 2011.  This meeting was requested in response to the Risk and Technology Review (RTR) of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the pulp and paper industry.

Meeting Attendees:

Rachel Agnew, EPA				Ron Myers, EPA
Traylor Champion, Georgia-Pacific		John Pinkerton, NCASI
Mike Curtis, Georgia-Pacific			Jim Rabe, Masonite International
Robin Dunkins, EPA				Bill Schrock, EPA
Steve Fruh, EPA 				Tim Smith, EPA
Rich Garber, Boise Inc.			Kelley Spence, EPA
Katie Hanks, RTI				Russell Strader, Boise Cascade, L.L.C.
Timothy Hunt, AF&PA/AWC		Carole Strapper, Temple-Inland
Ashok Jain, NCASI				Nick Swanson, EPA
Rhea Jones, EPA				Jim Taylor, MWV
Rob Kaufmann, KCPS			Elineth Torres, EPA
Debra Lane, Rayonier				Vipin Varma, NCASI
Amy Marshall, URS				Chet Wayland, EPA
Scott Mathias, EPA				Stephen Woock, Weyerhaeuser
Marguerite McLamb, EPA

Discussion Points:

   *    Review agenda (Attachment 1)
   *    RTR measurement policy
         o          Discussed addressing sampling below detection limit
         o          Additional monitoring to improve standard
         o          Discussed use of ERT
   *    RTR progress
         o          Emissions summary and data review (Attachment 2)
         o          Regulation scope focuses on risk review as well as technology
         o          Excess emission allowance and SSM discussion
         o          ISIS update
   *    Division update
         o          Boiler/CISWI reconsideration tentatively by end of October
         o          Develop policy to handle dioxin issues
         o          Trying to consider all variability and issues
         o          AF&PA believes court can't re-open a MACT rule and require floors for unregulated emission points
         o          Uniform standards only apply to industry if referenced in the regulation
         o          Agency reviewing petition for information and completeness related to adding hydrogen sulfide to the HAP list
         o          Petition from Center for Biological Diversity to sue to update NSPS
   *    NAAQS Implementation
         o          Designations for ozone implementation and classification thresholds discussion
         o          Discussion of modeling for compliance
         o          Discussion of 1 hour NOx and SO2 values
   *    Cross state Rule
         o          Re-evaluating  -  looking back at 2008 reconsideration
         o          SIP notices
         o          Interagency review of BART

                                                                   Attachment 1

                                    Agenda
              EPA/American Forestry and Paper Association Meeting
                              September 29, 2011
                                   Room C114
                            Call-in #<PHONE_NUMBER>

1.  Open Meeting			8:00 am - 8:10 am
         > Introductions, Review Agenda
2.  RTR Measurement Policy - Ron Myers/Rachel Agnew			8:10 am - 8:30 am
3.  P&P RTR Update-Bill Schrock/John Bradfield/Kelley Spence		8:30 am - 9:30 am
4.  Cross State Rules  -  Tim Smith			9:30 am - 10:00 am
5.  SPPD			10:00 am - 10:45 am
6.  Break
7.  NAAQS Activity  -  Scott Mathias/AQPD				11:00 am - 11:45 am
8.  Wrap Up								11:45am - 12:00 noon

                                                                   Attachment 2


[Federal Register Volume 86, Number 105 (Thursday, June 3, 2021)]
[Rules and Regulations]
[Pages 29691-29694]
[FR Doc No: 2021-11689]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2020-0035]
RIN 1625-AA08

Special Local Regulation; East Passage, Narragansett Bay, RI

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is amending an existing special local
regulation for certain waters of the East Passage, Narragansett Bay,
RI. This action is necessary to provide for the safety of life on these
navigable waters near East Passage, Narragansett Bay, RI, during a sail
boat race. This regulation would prohibit persons and vessels from
entering the special local regulation unless authorized by the Captain
of the Port Sector Southeastern New England or a designated
representative.

DATES: This rule is effective July 6, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
amended regulation, call or email LT Benjamin Aaronson, Waterways
Management Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Southeastern New England

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

II. Background Information and Regulatory History

    The Captain of the Port Sector Southeast New England (COTP) is
amending an existing special local regulation found in 33 CFR 100.119
for certain waters of the East Passage, Narragansett Bay, RI. This
action is necessary to provide for the safety of life on these
navigable waters near East Passage, Narragansett Bay, RI, during a sail
boat race requiring a limited access area restricting vessel traffic
for safety purposes.
    On March 9, 2020, the Coast Guard published a notice of proposed
rulemaking (NPRM) titled Special Local Regulation; East Passage,
Narragansett Bay, RI (85 FR 13595). There we stated why we issued the
NPRM, and invited comments on our proposed regulatory action related to
this special local regulation. During the comment period that ended
April 8, 2020, two comments were recieved.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. Based on the nature of this sailboat race, large numbers of
participants and spectators, and event locations, the COTP has
determined that the potential hazards associated with the event listed
in this rule could pose a risk to participants or waterways users if
the normal vessel traffic were to interfere with the events. Possible
hazards include risks of injury or death from near or actual contact
among participant vessels and spectators or mariners traversing through
the regulated area. This purpose of this rule is to ensure the safety
of all waterway users, including event participants, spectators, and
vessels during this scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received two comments on the NPRM published
March 9, 2020 that were not relevant to this rulemaking. Both of these
comments were submitted anonymously and unrelated to this rulemaking.
There is one change in the regulatory text of this rule from the
proposed rule in the NPRM. The last longitudinal coordinate of
072[deg]22'83'' W was changed to 071[deg]22'83'' W in the first
regulated area due to a typing error.
    This rule amends a special local regulation found in 33 CFR 100.119
currently reads as follows:
    Regulated area. The regulated area includes all waters of
Narragansett Bay, Newport, RI, within the following points (NAD 83):

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
41[deg]27'51'' N                     071[deg]22'14'' W
41[deg]27'24'' N                     071[deg]21'57'' W
41[deg]27'09'' N                     071[deg]22'39'' W
41[deg]27'36'' N                     072[deg]22'55'' W
------------------------------------------------------------------------

    In the event that weather conditions prohibit a safe race start
within the approach to Newport Harbor, the race will begin offshore and
the following regulated area applies (NAD 83):

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
41[deg]26'04'' N                     071[deg]22'16'' W
41[deg]25'36'' N                     071[deg]21'58'' W
41[deg]25'45'' N                     071[deg]22'40'' W
41[deg]25'49'' N                     071[deg]22'56'' W
------------------------------------------------------------------------

    The amended regulation would be to expand the size of the first
regulated area and to adjust the latitude and longitude of the second
regulated area to encompass a new potential starting line for the race
to accommodate for ideal weather parameters. The special local
regulation would cover all navigable waters from an area just south of
Rose Island expanding just past Castle Hill, RI, and also an area near
Brenton Point. The amended location of the special local regulation is
as follows:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
41[deg]29'13'' N                     071[deg]20'07'' W
41[deg]29'41'' N                     071[deg]20'87'' W
41[deg]27'27'' N                     071[deg]22'00'' W
41[deg]27'45'' N                     071[deg]22'83'' W
------------------------------------------------------------------------

    In the event that weather conditions prohibit a safe race start
within the approach to Newport Harbor, the race will begin offshore and
the following regulated area applies (NAD 83):

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
41[deg]26'06'' N                     071[deg]22'27'' W
41[deg]25'60'' N                     071[deg]21'97'' W
41[deg]25'36'' N                     071[deg]22'65'' W
41[deg]25'82'' N                     071[deg]22'93'' W
------------------------------------------------------------------------

    The starting line will take place within one of the amended
regulated areas and will be decided prior to the race pending current
weather conditions. The starting line box will be the restricted part
of the waterway within the regulated area and that exact location will
be broadcasted prior to the race start. The duration of the special
local regulation is intended to ensure the safety of vessels and these
navigable waters before, during, and after the scheduled sail boat
race. No vessel or person is permitted to enter the special local
regulation without obtaining permission from the COTP or a designated
representative. They may be contacted on VHF-FM Channel 16 or by phone
at<PHONE_NUMBER>. Persons and vessels permitted to enter this special
local regulation must transit at their slowest safe speed and comply
with all lawful directions issued by the COTP or a designated
representative. The COTP or a designated representative will inform the
public through broadcast notices to mariners of the enforcement period
for the special local regulation as well as any changes in the planned
schedule. The regulatory text we are amending appears at the end of
this document.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration and time-of-day of the special local regulation. We
expect the adverse economic impact to this area to be minimal. Although
this regulation may have adverse impact on the impact, the potential
impact will be minimized for the following reasons: The special local
regulation will be in effect for a maximum of 6 hours during the day of
the event; vessels will only be restricted from the area in the East
Passage of the Narragansett Bay during those limited periods when the
races are actually on going; there is an alternate route, the West
Passage of Narragansett Bay, that does not add substantial transit
time, is already routinely used by mariners, and will not be affected
by this special local regulation. Moreover, the Coast Guard

would issue a Broadcast Notice to Mariners (BNMs) via VHF-FM marine
channel 16 about the area, and the rule would allow vessels to seek
permission to enter the area.

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
amended 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
special local regulation may be small entities, for the reasons stated
in section IV.A above, this amended rule would not have a significant
economic impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This amended rule involves
a special local regulation lasting approximately 6 hours that would
prohibit entry within the regulated area. Such actions are
categorically excluded from further review under paragraph L 61 of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01.

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.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041.

0
2. Revise Sec.  100.119 to read as follows:

Sec.  100.119   Special Local Regulation; East Passage, Narragansett
Bay, RI.

    (a) Regulated area. (1) The regulated area includes all waters of
Narragansett Bay, Newport, RI, within the following points (NAD 83):

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
41[deg]29'13'' N                     071[deg]20'07'' W
41[deg]29'41'' N                     071[deg]20'87'' W
41[deg]27'27'' N                     071[deg]22'00'' W
41[deg]27'45'' N                     071[deg]22'83'' W
------------------------------------------------------------------------

    (2) In the event that weather conditions prohibit a safe race start
within the approach to Newport Harbor, the race will begin offshore and
the following regulated area applies (NAD 83):

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
41[deg]26'06'' N                     071[deg]22'27'' W
41[deg]25'60'' N                     071[deg]21'97'' W
41[deg]25'36'' N                     071[deg]22'65'' W
41[deg]25'82'' N                     071[deg]22'93'' W
------------------------------------------------------------------------

    (b) Effective period. This special local regulation is in effect
biennially on a date and times published in the Local Notice to
Mariners.
    (c) Special local regulations. (1) Entry into this area is
prohibited unless authorized by the Captain of the Port Sector
Southeastern New England (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 Southeastern New England.
    (2) Persons or vessels seeking to enter the regulated area must
request permission from the COTP or a

designated representative on VHF-FM channel 16 or by telephone at 508-
457-3211.
    (3) Persons and vessels permitted to enter this regulated area must
transit at their 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 through local notice to mariners
and Broadcast Notices to Mariners of the enforcement period for the
regulated area as well as any changes in the planned schedule.

    Dated: April 14, 2021.
C.J. Glander,
Captain, U.S. Coast Guard, Captain of the Port Sector Southeastern New
England.
[FR Doc. 2021-11689 Filed 6-2-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27250-27251]
[FR Doc No: 2011-11546]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0291]

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway,
Albemarle and Chesapeake Canal, Chesapeake, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
SR170 Centerville Turnpike Bridge across the Atlantic Intracoastal
Waterway, Albemarle and Chesapeake Canal, mile 15.2, at Chesapeake, VA.
The deviation is necessary to facilitate urgent mechanical structural
repairs to the swing span. Under this deviation, the drawbridge will be
allowed to operate on a limited schedule for the extent of the
effective period, specifically affecting four specific dates during the
effective time-period: May 14, 2011; May 15, 2011; June 4, 2011; and
June 5, 2011.

DATES: This deviation is effective from 8 a.m. on May 14, 2011 to 8
p.m. on June 5, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket USCG-2011-0291 and are available online by going to http://www.regulations.gov, inserting USCG-2011-0291 in the ``Keyword'' box,
and

then clicking ``Search''. This material is also available for
inspection or copying the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Waverly W. Gregory, Jr., Bridge Administrator, Fifth
Coast Guard District; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on reviewing the
docket, call Renee V. Wright, Program Manager, Docket Operations, (202)
366-9826.

SUPPLEMENTARY INFORMATION: The City of Chesapeake, who owns and
operates this swing-type bridge, has requested a temporary deviation
from the current operating regulations set out in 33 CFR 117.997(i), to
facilitate urgent mechanical and structural repairs to the swing span
mechanism.
    The deviation will not affect the current scheduled openings for
weekdays, as laid out in 33 CFR 117.997(i). The deviation will only
affect the scheduled openings on the following weekend dates: Saturday
May 14, 2011; Sunday May 15, 2011; Saturday June 4, 2011; and Sunday
June 5, 2011.
    Under this temporary deviation, on the four specific dates listed
above, the drawbridge will operate on a 4-hour opening schedule. This
schedule is meant to facilitate urgent mechanical and structural
repairs. Accordingly, on Saturday May 14, 2011, the drawbridge will
open on signal at: 8 a.m., 12 p.m., 4 p.m., and 8 p.m. On Sunday May
15, 2011, the drawbridge will open on signal at: midnight, 4 a.m., 8
a.m., 12 p.m., 4 p.m., and 8 p.m. On Saturday June 4, 2011, the
drawbridge will open on signal at: 8 a.m., 12 p.m., 4 p.m., and 8 p.m.
And, on Sunday June 5, 2011, the drawbridge will open on signal at:
midnight, 4 a.m., 8 a.m., 12 p.m., 4 p.m., and 8 p.m.
    If all of the mechanical and structural work is completed on May
14-15, 2011, then the deviation will not be enforced for June 4-5,
2011. A notice will be released for mariners should the deviation be
cancelled for June 4-5, 2011.
    Other than the four specific dates listed in this section, the
drawbridge will operate in accordance with the operating regulations
set out in 33 CFR 117.997(i).
    The SR170 Centerville Turnpike Bridge has a vertical clearance in
the closed position to vessels of four feet above mean high water.
Vessels may not transit under the bridge while it is in the closed
position.
    The Atlantic Intracoastal Waterway caters to a variety of vessels
from tug and barge traffic to recreational vessels traveling from
Florida to Maine. The Coast Guard has carefully coordinated the
restrictions with commercial and recreational waterway users.
Additionally, the Coast Guard will inform unexpected users of the
waterway through our local and broadcast Notices to Mariners of the
limited operating schedules for the bridge so that vessels can arrange
their transits to minimize any impacts caused by the temporary
deviation. The Atlantic Ocean is the alternate route for vessels and
the bridge will be able to open in the event of an emergency.
    In accordance with 33 CFR 117.35(e), the draw must return to its
original operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 28, 2011.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, Fifth Coast Guard District.
[FR Doc. 2011-11546 Filed 5-10-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55953-55954]
[FR Doc No: 2011-23224]

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

SECURITIES AND EXCHANGE COMMISSION

 [File No. 500-1]

American Capital Partners Limited, Inc., American Educators
Financial Corp. (n/k/a Asia Ventures Corp.), Austral Pacific Energy
Ltd., Bidville, Inc. (n/k/a PrimEdge, Inc.), Bio-Warm Corp. (n/k/a PHI
Gold Corp.), Black Rock Golf Corp. (a/k/a Aurus Corp.), Broadband
Wireless International Corp., BSK & Tech, Inc., and Buffalo Gold Ltd.;
Order of Suspension of Trading

September 7, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
American Capital Partners Limited, Inc. because it has not filed any
periodic reports since the period ended September 30, 2005.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
American Educators Financial Corp. (n/k/a Asia Ventures Corp.) because
it has not filed any periodic reports since the period ended September
30, 1993.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Austral Pacific Energy Ltd. because it has not filed any periodic
reports since the period ended December 31, 2007.

    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Bidville, Inc. (n/k/a PrimEdge, Inc.) because it has not filed any
periodic reports since the period ended September 30, 2005.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Bio-Warm Corp. (n/k/a PHI Gold Corp.) because it has not filed any
periodic reports since the period ended May 31, 2005.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Black Rock Gold Corp. (a/k/a Aurus Corp.) because it has not filed any
periodic reports since the period ended March 31, 1998.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Broadband Wireless International Corp. because it has not filed any
periodic reports since the period ended March 31, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
BSK & Tech, Inc. because it has not filed any periodic reports since it
filed a registration statement on January 23, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Buffalo Gold Ltd. because it has not filed any periodic reports since
the period ended December 31, 2007.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m.
E.D.T. on September 7, 2011, through 11:59 p.m. E.D.T. on September 20,
2011.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2011-23224 Filed 9-7-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: July 3, 2008 (Volume 73, Number 129)]
[Notices]
[Page 38253-38254]
[DOCID:fr03jy08-104]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-28322]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

 June 27, 2008.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
June, 2008. A copy of each application may be obtained for a fee at the
SEC's Public Reference Branch (tel.<PHONE_NUMBER>). An order granting
each application will be issued unless the SEC orders a hearing.
Interested persons may request a hearing on any application by writing
to the SEC's Secretary at the address below and serving the relevant
applicant with a copy of the request, personally or by mail. Hearing
requests should be received by the SEC by 5:30 p.m. on July 22, 2008,
and should be accompanied by proof of service on the applicant, in the
form of an affidavit or, for lawyers, a certificate of service. Hearing
requests should state the nature of the writer's interest, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

OFI Tremont Market Neutral Hedge Fund [File No. 811-21109]

    Summary: Applicant, a closed-end investment company, seeks an order

declaring that it has ceased to be an investment company. On April 29,
2008, applicant transferred its assets to OFI Tremont Core Strategies
Hedge Fund, based on net asset value. Expenses of $18,500 incurred in
connection with the reorganization were paid by OppenheimerFunds, Inc.,
applicant's investment adviser.
    Filing Dates: The application was filed on June 5, 2008, and
amended on June 23, 2008.
    Applicant's Address: 6803 S. Tucson Way, Centennial, CO 80112.

UBS Sequoia Fund, L.L.C. [File No. 811-10075]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
21, 2007, applicant made a liquidating distribution to its
shareholders, based on net asset value. Expenses of $5,900 incurred in
connection with the liquidation were paid by applicant.
    Filing Date: The application was filed on June 4, 2008.
    Applicant's Address: c/o UBS Financial Services Inc., 51 West 52nd
St., New York, NY 10019.

Tremont Oppenheimer Absolute Return Fund [File No. 811-21541]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on June 10, 2008.
    Applicant's Address: 6803 S. Tucson Way, Centennial, CO 80112.

Citizens Funds [File No. 811-3626]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 4, 2008, applicant transferred its
assets to Sentinel Group Funds, Inc., based on net asset value.
Expenses of approximately $958,237 incurred in connection with the
reorganization were paid by Citizen Advisers, Inc., applicant's
investment adviser, and Sentinel Asset Management, Inc., the acquiring
fund's investment adviser.
    Filing Dates: The application was filed on May 9, 2008, and amended
on June 9, 2008.
    Applicant's Address: One Harbour Pl., Suite 400, Portsmouth, NH
03801.

CCMA Select Investment Trust [File No. 811-10441]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has never made a public offering of
its securities and does not propose to make a public offering or engage
in business of any kind.
    Filing Dates: The application was filed on May 13, 2008, and
amended on May 29, 2008.
    Applicant's Address: c/o CCM Advisors, LLC, 190 South LaSalle St.,
Suite 2800, Chicago, IL 60603.

Cova Variable Annuity Account Four [File No. 811-6543]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant requests deregistration based on
abandonment of registration. Applicant is not now engaged, or intending
to engage, in any business activities other than those necessary for
winding up its affairs.
    Filing Date: The application was filed on May 30, 2008.
    Applicant's Address: MetLife Investors Insurance Company, 5 Park
Plaza, Suite 1900, Irvine, CA 92614.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-15065 Filed 7-2-08; 8:45 am]

BILLING CODE 8010-01-P