[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Page 23242]
[FR Doc No: 2012-9273]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14329-000]

 Grand Coulee Project Hydroelectric Authority; Notice of
Preliminary Permit Application Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Competing Applications

    On December 1, 2011, the Grand Coulee Project Hydroelectric
Authority filed an application for a preliminary permit, pursuant to
section 4(f) of the Federal Power Act (FPA), proposing to study the
feasibility of the Banks Lake Pumped Storage Project (Banks Lake
Project or project) to be located on Banks Lake and Franklin D.
Roosevelt Lake (Roosevelt Lake), near the town of Grand Coulee, Douglas
and Grant Counties, Washington. The project would be located on federal
lands administered by the U.S. Bureau of Reclamation (Reclamation) and
the U.S. Bureau of Land Management (BLM). The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project has two alternatives:

Alternative 1

    The proposed project would use Reclamation's existing Banks Lake as
the upper reservoir and Roosevelt Lake as the lower reservoir. The
proposed project would consist of the following new facilities: (1) An
upper reservoir inlet/outlet structure equipped with trash racks; (2) a
1.5-mile-long penstock consisting of a vertical shaft, power tunnel
segments, and a tailrace section, extending between the upper reservoir
inlet/outlet and the reversible turbine/generator units in the
powerhouse; (3) an underground powerhouse containing four reversible
turbine/generator units rated for 250 megawatts (MW) each, for a total
installed generation of 1,000 MW, or a powerhouse located on the shore
of Roosevelt Lake, also containing four 250-MW reversible turbine/
generator units; (4) a 2-mile-long, 500-kilovolt (kV) transmission line
extending from the project powerhouse to an existing 500-kV substation;
and (5) appurtenant facilities. The estimated annual generation of
Alternative 1 for the Banks Lake Project would be 2,263 gigawatt-hours
(GWh).

Alternative 2

    The proposed project would use Reclamation's existing Banks Lake as
the lower reservoir. The proposed project would consist of the
following new facilities: (1) A new 312-acre upper reservoir
constructed approximately 3,000 feet west of the existing Banks Lake,
impounded by three earth and rockfill embankments, each with a crest
elevation of 2,300 feet above mean sea level; (2) an upper reservoir
inlet/outlet structure equipped with trash racks; (3) a 620-foot-long,
43-foot-diameter vertical shaft connecting the upper reservoir inlet/
outlet structure to the power tunnels; (4) four 1,700-foot-long, 17-
foot-diameter power tunnels leading from the vertical shaft to the
powerhouse; (5) an underground powerhouse containing four reversible
turbine/generator units rated for 260 MW each, for a total installed
generation of 1,040 MW; (6) a 25-foot-diameter tailrace tunnel between
the powerhouse and the existing Banks Lake; (7) a 2.4-mile-long, 500-kV
transmission line extending from the project powerhouse to a new 500-kV
substation; and (8) appurtenant facilities. The estimated annual
generation of Alternative 2 for the Banks Lake Project would be 2,978
GWh.
    Applicant Contact: Mr. Ronald K. Rodewald, Secretary-Manager, Grand
Coulee Project Hydroelectric Authority, P.O. Box 219, Ephrata, WA
98823; phone:<PHONE_NUMBER>.
    FERC Contact: Jennifer Harper; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14329) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: April 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-9273 Filed 4-17-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Proposed Rules]
[Pages 22925-22928]
[FR Doc No: 2023-07828]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0928; Project Identifier MCAI-2023-00134-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS A300 B4-600, B4-600R, and F4-600R series airplanes,
and Model A300 C4-605R Variant F airplanes (collectively called Model
A300-600 series airplanes). This proposed AD was prompted by a
determination that new or more restrictive airworthiness limitations
are necessary. This proposed AD would require revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations, as specified in a European
Union Aviation Safety Agency (EASA) AD, which is proposed for
incorporation by reference (IBR). The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 30,
2023.

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 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.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0928; 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 NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.

Material Incorporated by Reference

     For material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email: [email protected]; website: easa.europa.eu.
You may find this material on the EASA website: ad.easa.europa.eu. It
is also available at regulations.gov under Docket No. FAA-2023-0928.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th Street, Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th Street, Des Moines, WA 98198; 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-2023-0928; Project Identifier
MCAI-2023-00134-T'' 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
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 Dan
Rodina, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary that
the FAA receives which is not specifically designated as CBI will be
placed in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2023-0017, dated January 23, 2023
(EASA AD 2023-0017) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model A300B4-601, A300B4-603,
A300B4-620, A300B4-622, A300B4-605R, A300B4-622R, A300C4-605R Variant
F, A300C4-620, A300F4-605R and A300F4-622R airplanes. Model A300C4-620
airplanes are not certificated by the FAA and are not included on the
U.S. type certificate data sheet; this proposed AD therefore does not
include those airplanes in the applicability. The MCAI states that new
or more restrictive airworthiness limitations have been developed.
    EASA AD 2023-0017 specifies that it requires a task (limitation)
already in Airbus A300-600 Airworthiness Limitations Section (ALS) Part
4, System Equipment Maintenance Requirements (SEMR), Revision 03 that
is required by EASA AD 2017-0202, dated October 12, 2017 (which
corresponds to FAA AD 2018-18-21, Amendment 39-19400 (83 FR 47054,
September 18, 2018) (AD 2018-18-21)), and that incorporation of EASA AD
2023-0017 invalidates (terminates) prior instructions for that task.
This proposed AD, therefore would, for the tasks identified in the
service information referenced in EASA AD 2023-0017, terminate the
limitations required by paragraph (g) of AD 2018-18-21, for Model
A300B4-601, A300B4-603, A300B4-620, A300B4-622, A300B4-605R, A300B4-
622R, A300C4-605R Variant F, A300F4-605R and A300F4-622R airplanes
only.
    The FAA is proposing this AD to address the risks associated with
the effects of aging on airplane systems. The unsafe condition, if not
addressed, could change system characteristics, leading to an increased
potential for failure of certain life-limited parts, and reduced
structural integrity or controllability of the airplane. You may
examine the MCAI in the AD docket at regulations.gov under Docket No.
FAA-2023-0928.

Related Service Information Under 1 CFR Part 51

    EASA AD 2023-0017 specifies new or more restrictive airworthiness
limitations for airplane structures and safe life limits. 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 ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, which are specified in EASA AD
2023-0017 described previously, except for any differences identified
as exceptions in the regulatory text of this proposed AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions and intervals is required by 14 CFR
91.403(c). For airplanes that have been previously modified, altered,
or repaired in the areas addressed by this proposed AD, the operator
may not be able to accomplish the actions described in the revisions.
In this situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance (AMOC)
according to paragraph (k)(1) 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 some 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, the
FAA proposes to incorporate EASA AD 2023-0017 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2023-0017 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 2023-0017 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 2023-
0017. Service information required by EASA AD 2023-0017 for compliance
will be available at regulations.gov by searching for and locating
Docket No. FAA-2023-0928 after the FAA final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and intervals
are approved as an AMOC in accordance with the procedures specified in
the AMOC paragraph under ``Additional AD Provisions.'' This new format
includes a ``New Provisions for Alternative Actions'' paragraph that
does not specifically refer to AMOCs, but operators may still request
an AMOC to use an alternative action, or interval.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 120 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate. Therefore, the agency estimates the average total cost per
operator to be $7,650 (90 work-hours x $85 per work-hour).

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 has 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:

Airbus SAS: Docket No. FAA-2023-0928; Project Identifier MCAI-2023-
00134-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 30, 2023.

(b) Affected ADs

    This AD affects AD 2018-18-21, Amendment 39-19400 (83 FR 47054,
September 18, 2018) (AD 2018-18-21).

(c) Applicability

    This AD applies to all Airbus SAS Model A300B4-601, A300B4-603,
A300B4-620, A300B4-622, A300B4-605R, A300B4-622R, A300C4-605R
Variant F, A300F4-605R and A300F4-622R airplanes, certificated in
any category.

(d) Subject

    Air Transport Association (ATA) of America Code: 05, Time
Limits/Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address the risks associated with the effects of
aging on airplane systems. The unsafe condition, if not addressed,
could change system characteristics, leading to an increased
potential for failure of certain life-limited parts, and reduced
structural integrity or controllability of the airplane.

(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
2023-0017, dated January 23, 2023 (EASA AD 2023-0017).

(h) Exceptions to EASA AD 2023-0017

    (1) This AD does not adopt the requirements specified in
paragraphs (1) and (2) of EASA AD 2023-0017.
    (2) Paragraph (3) of EASA AD 2023-0017 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA 2023-0017 is on or before the applicable
``limitations'' as incorporated by the requirements of paragraph (3)
of EASA AD 2023-0017, or within 90 days after the effective date of
this AD, whichever occurs later.
    (4) This AD does not adopt the provisions specified in paragraph
(4) of EASA AD 2023-0017.
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2023-0017.

(i) Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2023-0017.

(j) Terminating Action for AD 2018-18-21

    For Model A300B4-601, A300B4-603, A300B4-620, A300B4-622,
A300B4-605R, A300B4-622R, A300C4-605R Variant F, A300F4-605R and
A300F4-622R airplanes only: Accomplishing the actions required by
this AD terminates the corresponding requirements of AD 2018-18-21,
for the tasks identified in the service information referenced in
EASA AD 2023-0017 only.

(k) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the person identified in paragraph (l)
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 local flight standards district office/
certificate holding district 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, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(l) Additional Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(m) 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 2023-0017,
dated January 23, 2023.
    (ii) [Reserved]
    (3) For EASA AD 2023-0017, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email:
[email protected]; website: easa.europa.eu. You may find this EASA
AD on the EASA website: ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th
Street, 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: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 8, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.

[FR Doc. 2023-07828 Filed 4-13-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63783-63784]
[FR Doc No: 2022-22817]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0401]

Donor Eligibility for Animal Cells, Tissues, and Cell- and
Tissue-Based Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry #254 entitled ``Donor
Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based
Products.'' FDA's Center for Veterinary Medicine is issuing this
guidance for sponsors, firms, individuals, and establishments that
participate in the manufacture of, or perform any aspect of, the donor
eligibility determination for animal cells, tissues, and cell- and
tissue-based products (ACTPs). ACTPs that are intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease or
ACTPs intended to affect the structure or function of the animal
generally meet the definition of a new animal drug under the Federal
Food, Drug, and Cosmetic Act. Donor eligibility is a critical component
of current good manufacturing practice (CGMP) when manufacturing ACTPs.
A donor should be considered eligible to donate ACTPs only if screening
of the donor shows that the donor is free from risk factors for, and
clinical evidence of, infection with relevant disease agents and
diseases, and the donor (and product/source material) test results for
relevant disease agents are negative or nonreactive.

DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2022.

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-0401 for ``Donor Eligibility for Animal Cells, Tissues, and
Cell- and Tissue-Based Products.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff

between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lynne Boxer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 23, 2021 (86 FR 52912), FDA
published the notice of availability for a draft guidance entitled
``Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-
Based Products'' giving interested persons until November 22, 2021, to
comment on the draft guidance. FDA received two submissions that
contained multiple comments on the draft guidance and those comments
were considered as the guidance was finalized. Editorial changes were
made to improve clarity, for example, by making clear that the final
guidance is intended to apply to allogeneic and xenogeneic ACTPs, as
opposed to autologous ACTPs, and by providing additional, suggested
donor screening and testing information that should be considered when
determining an ACTP donor's eligibility. The guidance announced in this
notice finalizes the draft guidance dated September 2021.
    This level 1 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 ``Donor Eligibility for Animal Cells,
Tissues, and Cell- and Tissue-Based Products.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22817 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P


 [Federal Register: August 26, 2008 (Volume 73, Number 166)] [ Notices]                [Page 50323] [DOCID:fr26au08-61]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8708-2]

  Notice of Expert Peer Review Meeting of the Draft Demonstration

of Alternative Asbestos Control Method Demolition for Two Asbestos-

Containing Buildings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of external peer review meeting.

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

SUMMARY: EPA is announcing that Versar, Inc., an EPA contractor for

external peer review, has convened a panel of experts and will conduct

an independent expert peer meeting September 11-12, 2008, to review the

two draft documents titled, Evaluation of the Alternative Asbestos

Control Method at Site Two (AACM2) for Demolition of Asbestos-

Containing Buildings, and Evaluation of the Alternative Asbestos

Control Method at Site Three (AACM3) for Demolition of Asbestos-

Containing Buildings. These reports were prepared by EPA's Office of

Research and Development (ORD) and are available through docket ID

number EPA-HQ-ORD-2008-0523 located at http://www.regulations.gov and

through http://www.epa.gov/region6/6xa/asbestos. Versar, Inc. invites

the public to register to attend this meeting as observers. The public

release of these draft documents is solely for the purpose of seeking

public comment and external peer review, and these draft reports do not

represent and should not be construed to represent any EPA policy,

viewpoint, or determination.

DATES: The external peer review panel meeting will be September 11-12,

2008, and begin at 9 a.m. and end by 5 p.m. each day.

ADDRESSES: The independent expert external peer review meeting will be

held at the U.S. Environmental Protection Agency's National Risk

Management Research Laboratory, located at 26 West Martin Luther King

Drive, Cincinnati, OH. Members of the public may attend the meeting as

observers and there will be a limited time set aside for comments from

the public each day. Pre-registration is strongly recommended as space

is limited and reservations will be accepted on a first-come-first-

served basis. To attend this meeting, register by September 8, 2008, by

visiting http://epa.versar.com/aacm or contact Ms. Kathy Coon of

Versar, Inc., 6850 Versar Center, Springfield, VA, 22151, at 703-750-

3000, and via e-mail at<EMAIL_ADDRESS>You will be asked for your

name, contact information, the organization you represent, and your

title. If space allows, telephone and fax registrations will continue

to be accepted after this date, including on-site registration. Please

indicate if you intend to make an oral statement during the public

comment period at the meeting, which will be limited to a maximum of

five minutes per commenter.

SUPPLEMENTARY INFORMATION: EPA is submitting the draft reports for

independent, external scientific and technical peer review. The draft

reports provide the documentation and scientific evaluation of the

environmental effectiveness of the draft AACM protocol as a possible

alternative technology in controlling multimedia asbestos emissions

during demolition of asbestos-containing buildings, as required by the

existing Asbestos National Emission Standard for Hazardous Air

Pollutants (NESHAP). The draft AACM demolition protocol was used on two

separate buildings. One building contained NESHAP-regulated quantities

of asbestos-containing transite siding and the second building

contained NESHAP-regulated quantities of asbestos-containing popcorn

ceiling and wall surfacing material. In addition to assessing the

environmental effectiveness of the draft AACM technology, these two

draft reports assess the costs and time requirements of the application

of the AACM protocol in these situations, as well as document lessons

learned in each instance. The public release of these draft documents

is solely for the purpose of seeking public comment and peer review,

and does not represent and should not be construed to represent any EPA

policy, viewpoint, or determination.

    Dated: August 20, 2008.

M. Dannel,

Acting Director, Office of Science Policy, Office of Research and

Development.

 [FR Doc. E8-19750 Filed 8-25-08; 8:45 am]

BILLING CODE 6560-50-P


 I

 EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITICIN:S PUBLISHED IN THE FEDERAL REGISTER

 EPA Registration Division contact: [Tony Kish,703-308-9443]

 INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In Cil:!ic s where the outline element does not apply,please insert   11NA-Remove" and maintiliin the outline.Please do not change the margins,font,or format in your pesticide petition.Simply replace the instructions that  appear in green,i.e., 11[insert compan::::r name]," with the information specific to your action.

 TEMPLATE:

  [Syngenta Crop Protection LLC] [Syngenta Crop Protection LLC. PP#]        EP :: has received a pes+icide petition PP#	fron [Syngenta Crop Protectio r  LLC.,P.O. Box 18300,Greensboro, NC 27419-8300] proposing. pursuant to section  408{d) ofthe Federal..ood, Drug,anJ Cosmetic Act (FFDCA), 21U.S.C. 346a(d), to amend 40 CFR part 180.475.

       1.   by hrreasing t'le establisred tolerance for residueof [Difenoconazole ::. {2-           [2-chloro-4-(4-chlorophenoxy)]phenyl-4-methyl-1,3-dioxolan-2-ylmethyl] -l.H-           1,2,4,-triazole) ]  n or on toe raw agriculturalco 	m 11Hy [Fruit,pome,gr oup

          11-10] tron [1] lPPm) to [3] ppm an   [apple,wet pomace] 'rom [4.5] (p, 	')           to [7.5] ppm.

 EPA has determined that the petition contains data or inform tion regarding the elements set forth in section 408 (d)(2) of  FDDCA; however,EPA has not fully evalu  ted the sufficiency of the submitted data at this time or whether the data supports gran mg of the petition. Additional data may be needed before EPA rules on the petition.

 A. Residue Chemistry

       1. Plant metabolism.

 The nature  of  the  residues  in plants  is understood for  the  purpose  of  the  propc sed tolerance.  The metabolism  of  14C-difenoconazole has been studied  using both  p 'tenyl and  triazole   labels  in  wheat,  tomatoes,  potatoes, grapes,   and  spring  rape.    The  metabolic pathway was the same in these four  separate and distinct  crops.  Therebre, the  metabolism of  difenoconazole is considered  to  be  adequately  understood f:1·· all crops,per EPA Test Guideline 860.1300.

       2 Anal·,tical '71ethod. i. Food [Syngenta Crop Protection,Inc. has submitted ;;  practical analytical method  (AG-5758,master  record identification (MRID) No.  428065-04) for detecting and measuring levels of difenoconazole in or on food with  t limit  of quantitation (LOQ) that allows monitoring of food with residues at or above the levels set in the proposed tolerances.  EPA has validated this method and copies ha'd:! been provided to FDA for insertion  into pesticide analytical manual (PAM) II. Method REM 147.08 (MRID 46950222) is also available for enforcement method,for the determination of residues of difenoconazole in crops.Residues are qualified by liquic' chromatography (LC)/mass spectrometry (MS)/(MS) The method is available to any:t ne who is interested,and may be obtained  from the Field Operations Division, Office ol Pesticide Programs.

 ii. Livestock. Syngenta Crop Protection,Inc. has submitted a practicalanalytical met hod (AG-544A, MRID-43292401) for detecting and measuring levels of difenoconazole in or on cattle tissues and milk and poultry tissues and eggs,with a LOQ that allows monitoring of food with residues at or above the levels set in the proposed toleranu::s. EPA has validated this method and copies have been provided to FDA for insertion into PAM II. The method is available to anyone who is interested,and may be obtained ' r om the Field Operations Division,Office of Pesticide Programs.  Tolerances in meat,milk. poultry or eggs were established for enforcement purposes.]

 3 MC!gn::tude of 'esidues  [Syngenta conducted  adequate magnitude  of residut trials on Fruit, pome,group 11-10 under OPPTS 860.1500 to support  the requested  Jse of difenoconazole. These residue trials satisfy the requested tolerance on Fruit,por·11!,. group 11-10.]

 B. Toxicological Profile

 EPA has evaluated  the available toxicity data and considered its validity,complete ':::!SS, and reliability as well as the relationship of the results of the studies to human risk   EPA has also considered  available information concerning the  variability of the  sensiti::  ties of major  identifiable subgroups of consumers, including infants  and children.    Sp r.ific

 information on the studies received and the nature  of the toxic effects cause  by difenoconazole  as  well  as  the   no-observed-adverse-effect-level  (NOAEL} from   the toxicity         stu ...1:          --...         '"'c                          at        the        following       we   .ite: http://edocket.access.gpo.gov/2010/2010-9759.htm.  A summary of the toxicolc ,ical endpoints for l.:  .................... -     e ..:;eu iO::   m....a..  ,-,sk assessment is discussed in Unit III.A  and B. of the final rule published in the Federal Register of April 28, 2009 (75 FR  r: ges  22256-22263} (FRL-8817-3}.

       1.Acute toxicity.  [Insert text.]

       2.Genotoxicty. [Insert text.]

       3. Reproductive and developmental toxicity. [Insert text.]

       4. Subchronic toxicity. [Insert text.]

       5.Chronic toxicity  [Insert text.]

       6. Animal metabolism.  [Insert text.]

       7. Metabolite toxicology  [Insert text.]

       8. Endocrine disruption. [Insert text.]

 C. Aggregate Exposure

 1. Dietary exposure  [Tier Ill acute,short-term and chronic dietary exposure evaluations were performed for difenoconazole,1-[2-[2-chloro-4-(4- chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole,using t e Dietary Exposure Evaluation Model (DEEM-FCID(TM) Version 3.16} from Exponent and

 consumption data from the USDA NHANES 'What We Eat in America" survey,2003-  2008. These difenoconazole exposure assessments included all current  and pendin · (rapeseed, Crop Group 20) uses plus proposed new post-harvest  uses on pome fruit (Crop Group 11-10) and foliar application on dried legumes (Crop Group GC). These assessments utilized  residue data from field trials where difenoconazole was applie:  at the maximum intended use rate and samples were harvested at the minimum pre harvest interval  (PHI) to obtain maximum  residues. Empirically derived processing factors were used in these assessments when available;all other processing factors  _sed the DEEM-FCID(TM) Version 7.87 defaults.  Secondary residues in beef liver and kidne:: 1 were estimated  based on "maximum reasonably balanced diets" and transfer information from feeding studies. Percent crop treated  (%CT) values were estimate:! based upon economic,pest, and competitive pressures. Drinking water estimates v::.::re selected using the higher of the estimated  drinking water concentrations (EDWCs) fn· surface and ground  water.

 i. Food  [Acute exposure.  Acute (food only) risk assessments for difenoconazole we·e performed for all population subgroups using an acute reference dose (aRfD) of  0.25 mg/kg-bw/day, based upon a neurotoxicity study in rats with a no observed adverse effect level (NOAEL) of 25 mg/kg-bw/day and an uncertainty factor (UF) of  100X. The lOOX safety factor includes intra- and inter-species variations;no additioP =11  FQPA safety factor was applied.  For the purpose of the aggregate risk assessment,·:t,e exposure value was expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent ofthe acute reference dose (%aRfD). At the 99.9th percentile,acute (food only) exposure to the U.S. population resulted in cl MOE of 702 (14.2% of the aRfD of 0.25 mg/kg-bw/day). The most exposed sub population was children (1-2 years old) with a MOE of 344 (29.0% of the aRfD of 0.2.3 mg/kg-bw/day). Since the Benchmark MOE for this assessment was 100 and since t' e EPA generally has no concern for exposures above the Benchmark MOE or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from acute dietary (food) exposure to residues arising from all curnnt, pending, and proposed uses for difenoconazole].

 Chronic Exposure. Chronic (food only) risk assessment for difenoconazole were performed for all population subgroups using a chronic reference dose (cRfD) of  0.01mg/kg-bw/day, based on a combined chronic toxicity/carcinogenicity study in r  ts with a no observed adverse effect level (NOAH)  of 0.96 mg/kg-bw/day and an uncertainly factor of lOOX.  The lOOX safety factor includes intra- and inter-species variations; no additional FQPA safety factor was applied.  For the purpose of the

 aggregate risk assessment,the exposure values were expressed in terms of margin col  exposure (MOE), which was calculated by dividing the NOAEL by the exposure for en;  h

 population subgroup. In addition,exposure was expressed as a percent of the chror ic reference dose (%cRfD). Chronic (food only) exposures to the U.S. population resui1"E!cl in a MOE of 1,201(8.0% of the cRfD of 0.01mg/kg-bw/day). The most exposed sub· population was children (1-2 years old) with a MOE of 366 {26.2% of the cRfD of 0.01 mg/kg-bw/day). Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the Benchmark MOE or below 10C% of the reference  dose,Syngenta believes that there is a reasonable certainty that no harm will result from  chronic dietary (food) exposure to residues arising from all current,pending, and proposed uses for difenoconazole.

 Cancer.	A cancer dietary assessment was not conducted. Difenoconazole is classifi( d as a Group C,"possible human carcinogen," with a non-linear (MOE) approach for human risk characterization (CPRC Document, 7/27/94,Memo, P. V. Shah, March 3,  2007, HED Doc. No. 0054532).

 ii. Drinking water. [The Estimated Drinking Water Concentrations (EDWCs) of difenoconazo,le (CGA169374) determined as total toxic residues of difenoconazole 21 1d its degradate (CGA205375) were determined using Tier I models SCI-GROW (Screen 1g Concentration in Ground Water) to estimate pesticide concentrations in ground wa':f't and Tier II model PRZM/EXAMS (Pesticide Root Zone Model/Exposure Analysis Mode ing System) to estimate  pesticide concentration in surface water.  All registered  and proposed uses on pome fruit  and legumes were assessed. Based on the PRZM/EXM/IS modeling, the currently registered grape use provided a surface water acute EDWC of  20.0 parts per billion (ppb) and a surface water chronic EDWC of 13.5 ppb. Based o · the SCI-GROW modeling, the currently registered golf course turf  use provided a ground water acute and chronic EDWC of 0.0136 ppb.  Since the surface water EDWCs excetd the ground water EDWC,the surface water values were used for risk assessment purposes and will be considered protective for any ground water exposure concern:.

 Acute Exposure from Drinking Water:   The acute surface water EDWC of 20.0 ppb \II'.as input  directly into the DEEM-FCIDT"' software as "water, direct and indirect,all sources" to model the acute drinking water exposures.  Exposure contributions at the 99.9th percentile of exposures were determined by taking the difference between the aggregate (food +drinking water) exposures and the food (alone) exposures for eacb population subgroup.  Acute drinking water exposure U.S.population resulted in a lvlOE of 28,902 {0.3% ofthe aRfD of 0.25 mg/kg-bw/day). The most exposed sub-populat:on was children (1- 2 years old) with a MOE of 18,811(0.5% of the aRfD of 0.25

 mg/kg/day). Since the Benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures above the Benchmark MOE or below 100% o.; the aRfD, Syngenta believes that there is a reasonable certainty that no harm will re!itJIt from acute drinking water exposure to residues arising from the registered,pending 11nd proposed uses for difenoconazole.

 Chronic Exposure from Drinking Water.  The chronic surface water EDWC ·)f  13.5 ppb was input directly into the DEEM-FCID software as "water, direct ant 1 indirect, all sources" to model the chronic drinking water exposures.   Chronic drinking water exposure to the U.S. population resulted in a MOE of 3,396 (2 b% of the cRfD of 0.01 mg/kg-bw/day).   Chronic drinking water exposure to the most exposed sub-population (all infants, <1 year old) resulted in a MOE of 1,317 (7.3% of the cRfD of 0.01 mg/kg-bw/day).   Since the Benchmark MOE for thiH assessment was 100 and since EPA generally has no concern for exposures above the Benchmark MOE or below 100% of the cRfD, Syngenta believes tl' 1t  there is a reasonable certainty that no harm will result from chronic drinking W<tter  exposure to residues arising from all registered, pending and proposed uses ror  difenoconazole.]

 2. Non Dieta-y Exposure The use of difenoconazole on ornamentals and flov.''l' gardens (Inspire(R), Ready-to-Use spray) and golf courses (Quadris ToprM, Heritage Top··", Briskway(TM)) may result in residential handler or post-application exposures to selecte:1 subgroups.  A short-term toxicological dermal and inhalation endpoint of 1.25 mg/kg bw/day was selected based upon the no observed adverse effect level (NOAEL) fron· a  2-generation reproductive study in rats with an uncertainty factor of lOOX, which  includes intra- and inter-species variations; no additional FQPA safety factor was applied.  Exposure values were expressed in terms of margin of exposure (MOE), whi·:' was calculated by dividing the NOAEL by the exposure for each subgroup.  Adult gardeners 19+ years old had a short-term residential MOE of 249 and youth gardenr:.1 s had a short-term residential MOE of 363; there were no other exposed subgroups.  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has

 no concern for exposures above the Benchmark MOE,Syngenta believes that there i, a reasonable certainty that no harm will result from short-term residential exposure to residues arising from all current,pending,and proposed uses for difenoconazole.

 D. Cumulative Effects

 [Cumulative Exposure to Substances  with a Common Mechanism of Toxicity. Section 408(b)(2)(D)(v) requires that,when considering whether to establish,modift, or revoke a tolerance,the Agency consider "available information" concerning the cumulative effects of a particular  pesticide's residues and "other substances that have a common  mechanism of toxicity". An ongoing series of studies being conducted by thE! U.S. Triazole Task Force (USTIF) are designed to provide the Agency with more  complete  toxicological and residue information for 1,2,4 triazole and two conjugate:::. triazolylalanine and triazolyl acetic acid, metabolites common to most of the triazole fungicides. Upon completion of review of those data,EPA will prepare a more sophisticated assessment based on the revised toxicological and exposure database·:; For the purposes of this tolerance action,the EPA has not assumed that difenocona;::,)le has a common mechanism  of toxicity with other substances.]

 E. Safety Determination

 1 US   roo"1a i  n. [The acute dietary exposure analysis (food plus water) showed that exposure from all current,pending and proposed  uses of difenoconazo' :! would result in a MOE of 685 (14.6% of the aRfD of 0.25 mg/kg-bw/day) for the gen1:-ral U.S.population, which exceeds the Benchmark MOE of 100.  For the short-term aggregate exposure analysis the corresponding food, water and residential MOEs w1:.re aggregated using the inverse MOE approach.  The short-term aggregate (food,drinl:ing water,and residential) MOE was 205 for the general U.S.population,which exceed.: ·the Benchmark MOE of 100. The chronic dietary exposure analysis (food plus water) showed that exposure from all current, pending,and proposed uses of difenoconazo  e resulted in a MOE of 887 (10.8% of the cRfD of 0.01mg/kg-bw/day) for the general J .S. population,which also exceeds the Benchmark MOE of 100.  Based on the complet1:11ess and reliability of the toxicity  data supporting these petitions,Syngenta believes tha·: there is a reasonable certainty that no harm will result from  aggregate exposure to residues arising from all current,pending,and proposed uses of difenoconazole,  including anticipated dietary exposure from food,water,and all other types of non··  occupational exposures.]

 2 'nfonts and children  [The acute dietary exposure analysis (food plus water: showed that exposure from all current, pending and proposed uses of difenoconazol:? would result in a MOE of 338 (29.5% of the aRfD of 0.25 mg/kg-bw/day) for the mo:1 sensitive population subgroup,children 1-2 years old,which exceeds the Benchmark MOE of 100. For the short-term aggregate exposure analysis the corresponding fooc , water and residential MOEs were aggregated using the inverse MOE approach. ThE! short-term aggregate (food, drinking water,and residential) MOE was 413 for child "( n

 (1-2 years),which exceeds the Benchmark MOE of 100.  The chronic dietary exposu analysis (food plus water) showed that exposure from all current,pending, and proposed uses of difenoconazole resulted in a MOE of 317 (30.3% of the cRfD of 0.01. mg/kg-bw/day) for the most sensitive population subgroup, children 1-2 years old, which exceeds the Benchmark MOE of 100.  Based on the completeness and reliabili :y of the toxicity  data supporting these petitions,Syngenta believes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to residues arising from all current,pending, and proposed uses of difenoconazole,including anticipated dietary exposure from food, water,and all ot · r types of non-occupational exposures.]

 F. International Tolerances

 [Codex Alimentarius Commission established Maximum Residue Limits (MRI.-) for difenoconazole in various agriculturalcommodities including asparagus,banana, beans,except broad bean and soya bean, broccoli,Brussels sprouts, cabbages,heac . carrot,cauliflower,  celeriac,celery,cherries,edible offal {mammalian),eggs, garlic, ginseng, grapes,leek,lettuce,head, lettuce, leaf, mango, meat, milks,nectarine, olilt:::!s, papaya,passion fruit,peach,peas (pods and succulent/immature seeds),plums (including prunes),pome fruits,potato, poultry meat,poultry,edible offal of,rape !;.- ed, soya bean (dry), sugar beet,sunflower seed,tomato,tree nuts,wheat, and wheat sl aw and fodder (dry).]


[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44179-44180]
[FR Doc No: 2022-15782]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-091, OMB Control No. 3235-0088]

Submission for OMB Review; Comment Request: Extension: Rule
15Ba2-5

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in Rule 15Ba2-5 (17 CFR
240.15Ba2-5), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.) (``Exchange Act'').
    On July 7, 1976, effective July 16, 1976 (see 41 FR 28948, July 14,
1976), the Commission adopted Rule 15Ba2-5 under the Exchange Act to
permit a duly-appointed fiduciary to assume immediate responsibility
for the operation of a municipal securities dealer's business. Without
the rule, the fiduciary would not be able to assume operation until it
registered as a municipal securities dealer. Under the rule, the
registration of a municipal securities dealer is deemed to be the
registration of any executor, administrator, guardian, conservator,
assignee for the benefit of creditors, receiver, trustee in insolvency
or bankruptcy, or other fiduciary, appointed or qualified by order,
judgment, or decree of a court of competent jurisdiction to continue
the business of such municipal securities dealer, provided that such
fiduciary files with the Commission, within 30 days after entering upon
the performance of his duties, a statement setting forth as to such
fiduciary substantially the same information required by Form MSD or
Form BD. The statement is necessary to ensure that the Commission and
the public have adequate information about the fiduciary.
    There is approximately one respondent per year that requires an
aggregate total of 4 hours to comply with this rule. This respondent
makes an estimated one annual response. Each response takes
approximately 4 hours to complete. Thus, the total compliance burden
per year is approximately four hours. The approximate internal
compliance cost per hour is $25, resulting in a total internal cost of
compliance of approximately $100 per year (i.e., 4 hours x $25).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open

for Public Comments'' or by using the search function. Written comments
and recommendations for the proposed information collection should be
sent by August 24, 2022 to (i) www.reginfo.gov/public/do/PRAMain and
(ii) David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: July 19, 2022.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-15782 Filed 7-22-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Proposed Rules]
[Page 64892-64894]
[DOCID:fr31oc08-22]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1155; Directorate Identifier 2008-NM-146-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model 717-200
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain McDonnell Douglas Model 717-200 airplanes. This proposed AD
would require modifying the wire installation of the auxiliary
hydraulic pump in the right wheel well of the main landing gear (MLG).
This proposed AD results from fuel system reviews conducted by the
manufacturer. We are proposing this AD to prevent a tire burst when the
MLG is in the retracted position from causing damage to the wire
assembly of the auxiliary hydraulic pump and subsequent electrical
arcing, creating the potential of an ignition source in the center wing
tank, which, in combination with flammable fuel vapors, could result in
a fuel tank explosion and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by December 15,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, 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 service information identified in this AD, contact Boeing
Commercial

Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach,
California 90846, Attention: Data and Service Management, Dept. C1-L5A
(D800-0024).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Ken Sujishi, Aerospace Engineer, Cabin
Safety/Mechanical and Environmental Systems Branch, ANM-150L, FAA, Los
Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-1155;
Directorate Identifier 2008-NM-146-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.
    Boeing analysis determined that the existing wire installation of
the auxiliary hydraulic pump for Model 717-200 airplanes is routed
within the ``tire burst'' area. Replacing the components in the wire
assembly of the auxiliary hydraulic pump with new components, and
routing the wire assembly installation outside of the tire burst area,
will minimize the possibility of wire damage and electrical arcing to
the center wing fuel tank. A tire burst when the main landing gear
(MLG) is in the retracted position might cause damage to the wire
assembly of the auxiliary hydraulic pump and subsequent electrical
arcing, creating the potential of an ignition source in the center wing
tank, which, in combination with flammable fuel vapors, could result in
a fuel tank explosion and consequent loss of the airplane.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 717-29A0009, dated
July 31, 2008. The service bulletin describes procedures for modifying
the wire installation of the auxiliary hydraulic pump in the right
wheel well of the MLG. The modification includes replacing the
components in the wire assembly of the auxiliary hydraulic pump with
new components, and routing the wire assembly installation outside of
the tire burst area.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in
the service information described previously.

Costs of Compliance

    We estimate that this proposed AD would affect 8 airplanes of U.S.
registry. We also estimate that it would take about 11 work-hours per
product to comply with this proposed AD. The average labor rate is $80
per work-hour. Required parts cost is minimal. Based on these figures,
we estimate the cost of this proposed AD to the U.S. operators to be
$7,040, or $880 per product.

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.
    We are 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

    We 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979), 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

McDonnell Douglas: Docket No. FAA-2008-1155; Directorate Identifier
2008-NM-146-AD.

Comments Due Date

    (a) We must receive comments by December 15, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to McDonnell Douglas Model 717-200
airplanes, certificated in any category; as identified in Boeing
Alert Service Bulletin 717-29A0009, dated July 31, 2008.

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent a tire burst when
the main landing gear (MLG) is in the retracted position from
causing damage to the wire assembly of the auxiliary hydraulic pump
and subsequent electrical arcing, creating the potential of an
ignition source in the center wing tank, which, in combination with
flammable fuel vapors, could result in a fuel tank explosion and
consequent loss of the airplane.

Compliance

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

Installation/Re-Routing

    (f) Within 60 months after the effective date of this AD: Modify
the wire installation of the auxiliary hydraulic pump in the right
wheel well of the MLG by doing all the applicable actions specified
in the Accomplishment Instructions of Boeing Alert Service Bulletin
717-29A0009, dated July 31, 2008.

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Los Angeles Aircraft Certification Office,
FAA, ATTN: Ken Sujishi, Aerospace Engineer, Cabin Safety/Mechanical
and Environmental Systems Branch, ANM-150L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
California 90712-4137; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    Issued in Renton, Washington, on October 24, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-25991 Filed 10-30-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42071-42072]
[FR Doc No: 2013-16898]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0268; FRL-9833-5]

Updates to Protective Action Guides Manual: Protective Action
Guides (PAGs) and Planning Guidance for Radiological Incidents

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed guidance; extension of comment period.

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

SUMMARY: The U.S. Environmental Protection Agency is announcing an
extension of the public comment period for the proposed guidance ``PAG
Manual: Protective Action Guides (PAGs) and Planning Guidance for
Radiological Incidents'' (the proposed guidance is hereinafter referred
to as ``PAGs''). The EPA published the proposed guidance in the Federal
Register, which included a request for comment, on April 15, 2013. The
public comment period was to end on July 15, 2013. The purpose of this
notice is to extend the public comment period an additional 60 days.

DATES: Written comments must be received on or before September 16,
2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0268, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Air and Radiation Docket and Information Center,
U.S. Environmental Protection Agency, Mailcode: 2822T, 1200
Pennsylvania Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, EPA West Building, Room
3334, 1301 Constitution Ave. NW., Washington, DC 20460. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0268. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the Agency without going through
www.regulations.gov your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the Agency may
not be able to consider your comment. Electronic files should avoid the
use of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about the Agency's
public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm. For additional instructions on
submitting comments, please refer to the notice of proposed rulemaking
(Section XI, Public Participation, of the SUPPLEMENTARY INFORMATION
section of the proposed rulemaking document).
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air and Radiation Docket
and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sara DeCair, Radiation Protection
Division, Center for Radiological Emergency Management, Mail Code
6608J, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER> ; fax
number:<PHONE_NUMBER>; email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

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

    1. Submitting Confidential Business Information (CBI). Do not
submit this information to the EPA through www.regulations.gov or
email. Clearly mark all of the information that you claim to be CBI.
For CBI information in a disk or CD ROM that you mail to the EPA, mark
the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number, subject heading,
Federal Register date and page number.
     Follow directions--the EPA may ask you to respond to
specific questions or organize comments by referencing the chapter
number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow it to be
reproduced.
     Illustrate your concerns with specific examples and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

B. How can I get copies of this document, the proposed rule and other
related information?

    The EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2007-0268. The EPA has also developed a Web site for the
proposed PAGs updates at: http://www.epa.gov/radiation/rert/pags.html.
Please refer to the original Federal Register notice on the proposed
guidance for detailed information on accessing information related to
the proposal.
    In response to requests for an extension, we are extending the
public comment period for the PAGs updates through September 16, 2013.
This extension will provide the public additional time to provide
comment on the proposed guidance.

    Dated: July 8, 2013.
Gina McCarthy,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2013-16898 Filed 7-12-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6323-6324]
[FR Doc No: 2021-01207]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0365; FRL-10018-32-ORD]

Board of Scientific Counselors (BOSC) Air and Energy Subcommittee
Meeting--February 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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

SUMMARY: The Environmental Protection Agency (EPA), Office of Research
and Development (ORD), gives notice of a virtual meeting of the Board
of Scientific Counselors (BOSC) Air and Energy (A-E) Subcommittee to
review science for air quality decisions and next generation methods--
wildfire focus.

DATES:
    1. The initial meeting will be held over three days via
videoconference:
    a. Wednesday, February 17, 2021, from 12 p.m. to 5 p.m. (EDT);
    b. Thursday, February 18, 2021, from 12 p.m. to 5 p.m. (EDT); and
    c. Friday, February 19, 2021, from 12 p.m. to 5 p.m. (EDT).
    Attendees must register by February 16, 2021.
    2. A BOSC deliberation will be held on March 18, 2021 from 2 p.m.
to 5 p.m. (EDT). Attendees must register by March 17, 2021.
    3. A final summary teleconference will be held on April 2, 2021
from 2 p.m. to 5 p.m. (EDT). Attendees must register by April 1, 2021.
    Meeting times are subject to change. This series of meetings are
open to the public. Comments must be received by February 16, 2021, to
be considered by the subcommittee. Requests for the draft agenda or
making a presentation at the meeting will be accepted until February
16, 2021.

ADDRESSES: Instructions on how to connect to the videoconference will
be provided upon registration at https://www.eventbrite.com/e/us-epa-bosc-air-and-energy-subcommittee-meeting-tickets-121242446421.
    Submit your comments to Docket ID No. EPA-HQ-ORD-2015-0365 by one
of the following methods:
     www.regulations.gov: Follow the online instructions for
submitting comments.

    Note: Comments submitted to the www.regulations.gov website are
anonymous unless identifying information is included in the body of
the comment.

     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0365.

    Note: Comments submitted via email are not anonymous. The
sender's email will be included in the body of the comment and
placed in the public docket which is made available on the internet.

    Instructions: All comments received, including any personal
information provided, will be included in the public docket without
change and may be made available online at www.regulations.gov.
Information claimed to be Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute will not be
included in the public docket, and should not be submitted through
www.regulations.gov or email. For additional information about the
EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Public Docket: Publicly available docket materials may be accessed
Online at www.regulations.gov.
    Copyrighted materials in the docket are only available via hard
copy. The telephone number for the ORD Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:
    The Designated Federal Officer (DFO), Tom Tracy, via phone/
voicemail at:<PHONE_NUMBER>; or via email at<EMAIL_ADDRESS>    Any member of the public interested in receiving a draft agenda,
attending the meeting, or making a presentation at the meeting should
contact Tom Tracy no later than February 16, 2021.

SUPPLEMENTARY INFORMATION: The Board of Scientific Counselors (BOSC) is
a federal advisory committee that provides advice and recommendations
to EPA's Office of Research and Development on technical and management
issues of its research programs. The meeting agenda and materials will
be posted to https://www.epa.gov/bosc.
    Proposed agenda items for the meeting include, but are not limited
to, the following: Science for air quality decisions and next
generation methods--wildfire focus.
    Information on Services Available: For information on translation
services, access, or services for individuals with disabilities, please
contact Tom Tracy at<PHONE_NUMBER> or<EMAIL_ADDRESS>To request
accommodation of a disability, please contact Tom Tracy at least ten
days prior to the meeting to give the EPA adequate time to process your
request.

(Authority: Pub. L. 92-463, 1, Oct. 6, 1972, 86 Stat. 770)

Mary Ross,
Director, Office of Science Advisor, Policy and Engagement.
[FR Doc. 2021-01207 Filed 1-19-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 2, 2009 (Volume 74, Number 104)]
[Notices]
[Page 26471-26473]
[DOCID:fr02jn09-132]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1999-5748; FMCSA-2000-8398; FMCSA-2001-9258; FMCSA-
2003-14223; FMCSA-2005-20027; FMCSA-2005-20560]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
6 individuals. FMCSA has statutory authority to exempt individuals from
the vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemption renewals
will provide a level of safety that is equivalent to, or greater than,
the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

DATES: This decision is effective June 30, 2009. Comments must be
received on or before July 2, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management

System (FDMS) Docket ID FMCSA-1999-5748; FMCSA-2000-8398; FMCSA-2001-
9258; FMCSA-2003-14223; FMCSA-2005-20027; FMCSA-2005-20560, using any
of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 6 individuals who have requested a renewal of
their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 6 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Edmund J. Barron                     Thomas E. Howard
Roger K. Cox                         Billy L. Johnson
Myron D. Dixon                       Clifford E. Masink

    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 6 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (64 FR 40404; 64 FR 66962; 67 FR 17102; 70 FR 25878; 72 FR
34062; 65 FR 78256; 66 FR 16311; 68 FR 13360; 70 FR 37891; 66 FR 17743;
66 FR 33990; 68 FR 35772; 70 FR 33937; 68 FR 10301; 68 FR 19596; 70 FR
16886; 70 FR 2701; 70 FR 16887; 70 FR 17504; 70 FR 30997; 72 FR 27624).
Each of these 6 applicants has requested renewal of the exemption and
has submitted evidence showing that the vision in the better eye
continues to meet the standard specified at 49 CFR 391.41(b)(10) and
that the vision impairment is stable. In addition, a review of each
record of safety while driving with the respective vision deficiencies
over the past two years indicates each applicant continues to meet the
vision exemption standards. These factors provide an adequate basis for
predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of two years is
likely to achieve a level of safety equal to that existing without the
exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by July 2, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 6 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision

requirements. That information is available by consulting the above
cited Federal Register publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these drivers, are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: May 22, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-12773 Filed 6-1-09; 8:45 am]

BILLING CODE 4910-EX-P