Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to OMB for review.

B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA. The ICR document that
the EPA prepared has been assigned EPA ICR number 2025.08. You can find
a copy of the ICR in the docket for this rule, and it is briefly
summarized here.
    We are proposing changes to the recordkeeping and reporting
requirements associated with 40 CFR part 63, subpart QQQQQ, in the form
of eliminating the SSM plan and reporting requirements, and increasing
reporting requirements for the semiannual report of deviation. We also
recalculated the estimated recordkeeping burden for records of SSM to
more accurately represent the removal of the SSM exemption, which is
discussed in more detail in the memorandum, ``Email Correspondence
estimating the cost of SSM reporting with Knowlton Technologies, LLC.''
    Respondents/affected entities: The respondents to the recordkeeping
and reporting requirements are owners or operators of facilities that
produce friction products subject to 40 CFR part 63, subpart QQQQQ.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart QQQQQ).
    Estimated number of respondents: Two facilities.
    Frequency of response: Initially and semiannually.
    Total estimated burden: The annual recordkeeping and reporting
burden for responding facilities to comply with all of the requirements
in the NESHAP, averaged over the 3 years of this ICR, is estimated to
be 535 hours (per year). Of these, 115 hours (per year) is the reduced
burden to comply with the proposed rule amendments. Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: The annual recordkeeping and reporting cost
for responding facilities to comply with all of the requirements in the
NESHAP, averaged over the 3 years of this ICR, is estimated to be
$35,200 (rounded, per year), including $544 annualized capital or
operation and maintenance costs. This results in a decrease of $7,400
(rounded, per year) to comply with the proposed amendments to the rule.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs via
email to [email protected], Attention: Desk Officer for the
EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after receipt, OMB must receive comments no
later than June 4, 2018. The EPA will respond to any ICR-related
comments in the final rule.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. There are no
small entities in this regulated industry.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments or the
private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. No tribal facilities are known to be engaged in
the friction material manufacturing industry that would be affected by
this action. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This action's health and risk assessments are contained in
sections III.A and IV.A and B of this preamble.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This action involves technical standards. Therefore, the EPA
conducted a search to identify potentially applicable voluntary
consensus standards. However, the Agency identified no such standards.
Therefore, the EPA has decided to continue the use of the weighing
procedures based on EPA Method 28 of 40 CFR part 60, appendix A
(section 10.1) for weighing of recovered solvent. A thorough summary of
the search conducted and results are included in the memorandum titled
``Voluntary Consensus Standard Results for Friction

Materials Manufacturing Facilities Residual Risk and Technology
Review,'' which is available in the docket for this action.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
    The documentation for this decision is contained in section IV.A of
this preamble and the technical report, ``Friction Materials
Manufacturing Demographic Analysis,'' which is available in the docket
for this action.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.

    Dated: April 23, 2018.
E. Scott Pruitt,
Administrator.

    For the reasons stated in the preamble, the EPA proposes to amend
title 40, chapter I, part 63 of the Code of Federal Regulations as
follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart QQQQQ--National Emission Standards for Hazardous Air
Pollutants for Friction Materials Manufacturing Facilities

0
 2. Section 63.9495 is amended by revising paragraphs (a) and (b) and
adding paragraph (e) to read as follows:

Sec.  63.9495  When do I have to comply with this subpart?

    (a) If you have an existing solvent mixer, you must comply with
each of the requirements for existing sources no later than October 18,
2005, except as otherwise specified at this section and Sec. Sec.
63.9505, 63.9530, 63.9540, 63.9545, and Table 1 to this subpart.
    (b) If you have a new or reconstructed solvent mixer for which
construction or reconstruction commenced after October 18, 2002, but
before May 4, 2018 you must comply with the requirements for new and
reconstructed sources upon initial startup, except as otherwise
specified at this section and Sec. Sec.  63.9505, 63.9530, 63.9540,
63.9545, and Table 1 to this subpart.
* * * * *
    (e) Solvent mixers constructed or reconstructed after May 3, 2018
must be in compliance with this subpart at startup or by [DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], whichever is later.
0
 3. Revise Sec.  63.9505 to read as follows:

Sec.  63.9505  What are my general requirements for complying with this
subpart?

    (a) Before [DATE 181 DAYS AFTER PUBLICATION OF FINAL RULE IN THE
FEDERAL REGISTER], for each existing source and each new or
reconstructed source for which construction or reconstruction commenced
after October 18, 2002, but before May 4, 2018 you must be in
compliance with the emission limitations in this subpart at all times,
except during periods of startup, shutdown, or malfunction. After [DATE
180 DAYS AFTER PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], for
each such source you must be in compliance with the emission
limitations in this subpart at all times. For new and reconstructed
sources for which construction or reconstruction commenced after May 3,
2018, you must be in compliance with the emissions limitations in this
subpart at all times.
    (b) Before [DATE 181 DAYS AFTER PUBLICATION OF FINAL RULE IN THE
FEDERAL REGISTER], for each existing source, and for each new or
reconstructed source for which construction or reconstruction commenced
after October 18, 2002, but before May 4, 2018, you must always operate
and maintain your affected source, including air pollution control and
monitoring equipment, according to the provisions in Sec.
63.6(e)(1)(i). After [DATE 180 DAYS AFTER PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER] for each such source, and after [DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for new and
reconstructed sources for which construction or reconstruction
commended after May 3, 2018, at all times you must operate and maintain
any affected source, including associated air pollution control
equipment and monitoring equipment, in a manner consistent with safety
and good air pollution control practices for minimizing emissions. The
general duty to minimize emissions does not require you to make any
further efforts to reduce emissions if levels required by the
applicable standard have been achieved. Determination of whether a
source is operating in compliance with operation and maintenance
requirements will be based on information available to the
Administrator which may include, but is not limited to, monitoring
results, review of operation and maintenance procedures, review of
operation and maintenance records, and inspection of the source.
    (c) Before [DATE 181 DAYS AFTER PUBLICATION OF FINAL RULE IN THE
FEDERAL REGISTER], for each existing source, and for each new or
reconstructed source for which construction commenced after October 18,
2002, but before May 14, 2018, you must develop a written startup,
shutdown, and malfunction plan according to the provisions in Sec.
63.6(e)(3). For each such source, a startup, shutdown, and malfunction
plan is not required after [DATE 180 DAYS AFTER PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER]. No startup, shutdown, and malfunction
plan is required for any new or reconstructed source for which
construction or reconstruction commenced after May 3, 2018.
0
4. Section 63.9530 is amended by revising paragraphs (a)(1) and (e) to
read as follows:

Sec.  63.9530  How do I demonstrate continuous compliance with the
emission limitation that applies to me?

    (a) * * *
    (1) For existing sources and for new or reconstructed sources for
which construction or reconstruction commenced after October 18, 2002,
but before May 4, 2018, before [DATE 181 DAYS AFTER PUBLICATION OF
FINAL RULE IN THE FEDERAL REGISTER], except for during malfunctions of
your weight measurement device and associated repairs, you must collect
and record the information required in Sec.  63.9520(a)(1) through (8)
at all times that the affected source is operating and record all
information needed to document conformance with these requirements.
After [DATE 180 DAYS AFTER PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER] for such sources, and after [DATE OF PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER] for new or reconstructed sources that
commenced construction after May 3, 2018, you must collect and record
the information required in Sec.  63.9520(a)(1) through (8) at all
times that the affected source is operating and record all information

needed to document conformance with these requirements.
* * * * *
    (e) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before [DATE 181 DAYS AFTER PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER], consistent with Sec. Sec.  63.6(e) and
63.7(e)(1), deviations that occur during a period of startup, shutdown,
or malfunction are not violations if you demonstrate to the
Administrator's satisfaction that you were operating in accordance with
Sec.  63.6(e)(1). The Administrator will determine whether deviations
that occur during a period of startup, shutdown, or malfunction are
violations, according to the provisions in Sec.  63.6(e). After [DATE
180 DAYS AFTER PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for
such sources, and after [DATE OF PUBLICATION OF FINAL RULE IN THE
FEDERAL REGISTER] for new or reconstructed sources which commence
construction or reconstruction after May 3, 2018, all deviations are
considered violations.
0
5. Section 63.9540 is amended by revising paragraphs (b)(4), (c)(2),
and (d) to read as follows:

Sec.  63.9540  What reports must I submit and when?

* * * * *
    (b) * * *
    (4) For existing sources and for new or reconstructed sources for
which construction or reconstruction commenced after October 18, 2002,
but before May 4, 2018, before [DATE 181 DAYS AFTER PUBLICATION OF
FINAL RULE IN THE FEDERAL REGISTER], if you had a startup, shutdown, or
malfunction during the reporting period and you took actions consistent
with your startup, shutdown, and malfunction plan, the compliance
report must include the information in Sec.  63.10(d)(5)(i). A startup,
shutdown, and malfunction plan is not required for such sources after
[DATE 180 DAYS AFTER PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER].
* * * * *
    (c) * * *
    (2) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before [DATE 181 DAYS AFTER PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER], information on the number, duration, and
cause of deviations (including unknown cause, if applicable), as
applicable, and the corrective action taken. After [DATE 180 DAYS AFTER
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for such sources,
and after [DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]
for new or reconstructed sources which commenced construction or
reconstruction after May 3, 2018, information on the number of
deviations to meet an emission limitation. For each instance, include
the date, time, duration, and cause of deviations (including unknown
cause, if applicable), as applicable, a list of the affected source or
equipment, an estimate of the quantity of each regulated pollutant
emitted over any emission limit, and a description of the method used
to estimate the emissions, and the corrective action taken.
    (d) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before [DATE 181 DAYS AFTER PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER], if you had a startup, shutdown, or
malfunction during the semiannual reporting period that was not
consistent with your startup, shutdown, and malfunction plan, you must
submit an immediate startup, shutdown, and malfunction report according
to the requirements in Sec.  63.10(d)(5)(ii). An immediate startup,
shutdown, and malfunction report is not required for such sources after
[DATE 180 DAYS AFTER PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER].
* * * * *
0
 6. Section 63.9545 is amended by revising paragraph (a)(2) and adding
paragraph (a)(3) to read as follows:

Sec.  63.9545  What records must I keep?

    (a) * * *
    (2) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before [DATE 181 DAYS AFTER PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER], the records in Sec.  63.6(e)(3)(iii)
through (v) related to startup, shutdown, or malfunction. For such
sources, it is not required to keep records in Sec.  63.6(e)(3)(iii)
through (v) related to startup, shutdown, or malfunction after [DATE
180 DAYS AFTER PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER].
    (3) After [DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER] for new or reconstructed sources which commenced construction
or reconstruction after May 3, 2018, and after [DATE 180 DAYS AFTER
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for all other
affected sources, in the event that an affected unit fails to meet an
applicable standard, record the number of deviations. For each
deviation, record the date, time and duration of each deviation.
    (i) For each deviation, record and retain cause of deviations
(including unknown cause, if applicable), a list of the affected source
or equipment, an estimate of the quantity of each regulated pollutant
emitted over any emission limit, and a description of the method used
to estimate the emissions.
    (ii) Record actions taken to minimize emissions in accordance with
Sec.  63.9505, and any corrective actions taken to return the affected
unit to its normal or usual manner of operation.
* * * * *
0
 7. Table 1 to subpart QQQQQ of part 63 is amended by:
0
 a. Removing the entry ``Sec.  63.6(a)-(c), (e)-(f), (i)-(j)'';
0
 b. Adding the entries ``Sec.  63.6(a)-(c), (i)-(j)'', ``Sec.
63.6(e)(1)(i)-(ii)'', ``Sec.  63.6(e)(1)(iii), (e)(2)'', ``Sec.
63.6(e)(3)'', ``Sec.  63.6(f)(1)'', and ``Sec.  63.6(f)(2)-(3)'' in
numerical order;
0
 c. Removing the entry ``Sec.  63.8(a)(1)-(2), (b), (c)(1)-(3), (f)(1)-
(5)'';
0
d. Adding the entries ``Sec.  63.8(a)(1)-(2)'', ``Sec.  63.8(b)'',
``Sec.  63.8(c)(1)(i), (iii)'', ``Sec.  63.8(c)(1)(ii), (c)(2),
(c)(3)'', and ``Sec.  63.8(f)(1)-(5)'' in numerical order;
0
e. Removing the entry ``Sec.  63.10(a), (b), (d)(1), (d)(4)-(5),
(e)(3), (f)''; and
0
 f. Adding the entries ``Sec.  63.10(a), (b)(1), (d)(1), (d)(4),
(e)(3), (f)'', ``Sec.  63.10(b)(2)(i), (ii), (iv), (v)'', ``Sec.
63.10(b)(2)(iii), (vi)-(xiv)'', and ``Sec.  63.10(d)(5)'' in numerical
order.
    The revisions and additions read as follows:

            Table 1 to Subpart QQQQQ of Part 63--Applicability of General Provisions to Subpart QQQQQ
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
              Citation                       Subject          Applies to subpart QQQQQ?         Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sec.   63.6(a)-(c), (i)-(j)........  Compliance with         Yes........................  ......................
                                      Standards and
                                      Maintenance
                                      Requirements.

                                                  * * * * * * *
Sec.   63.6(e)(1)(i)-(ii)..........  SSM Operation and       No, for new or               Subpart QQQQQ requires
                                      Maintenance             reconstructed sources        affected units to
                                      Requirements.           which commenced              meet emissions
                                                              construction or              standards at all
                                                              reconstruction after May     times. See Sec.
                                                              3, 2018. Yes, for all        63.9505 for general
                                                              other affected sources       duty requirement.
                                                              before [DATE 181 DAYS
                                                              AFTER PUBLICATION OF FINAL
                                                              RULE IN THE Federal
                                                              Register], and
                                                             No thereafter..............
Sec.   63.6(e)(1)(iii), (e)(2).....  Operation and           Yes........................  ......................
                                      Maintenance.
Sec.   63.6(e)(3)..................  SSM Plan Requirements.  No, for new or               Subpart QQQQQ requires
                                                              reconstructed sources        affected units to
                                                              which commenced              meet emissions
                                                              construction or              standards at all
                                                              reconstruction after May     times.
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before [DATE 181 DAYS
                                                              AFTER PUBLICATION OF FINAL
                                                              RULE IN THE Federal
                                                              Register], and
                                                             No thereafter..............
Sec.   63.6(f)(1)..................  SSM Exemption.........  No, for new or               Subpart QQQQQ requires
                                                              reconstructed sources        affected units to
                                                              which commenced              meet emissions
                                                              construction or              standards at all
                                                              reconstruction after May     times.
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before [DATE 181 DAYS
                                                              AFTER PUBLICATION OF FINAL
                                                              RULE IN THE Federal
                                                              Register], and
                                                             No thereafter..............
Sec.   63.6(f)(2)-(3)..............  Compliance with         Yes........................  ......................
                                      Nonopacity Emission
                                      Standards.

                                                  * * * * * * *
Sec.   63.8(a)(1)-(2)..............  Applicability and       Yes........................  ......................
                                      Relevant Standards
                                      for CMS.

                                                  * * * * * * *
Sec.   63.8(b).....................  Conduct of Monitoring.  Yes........................  ......................
Sec.   63.8(c)(1)(i)-(iii).........  Continuous Monitoring   No, for new or               ......................
                                      System (CMS) SSM        reconstructed sources
                                      Requirements.           which commenced
                                                              construction or
                                                              reconstruction after May
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before [DATE 181 DAYS
                                                              AFTER PUBLICATION OF FINAL
                                                              RULE IN THE Federal
                                                              Register], and
                                                             No thereafter..............
Sec.   63.8(c)(1)(ii), (c)(2),       CMS Repairs, Operating  Yes........................  ......................
 (c)(3).                              Paramaters, and
                                      Performance Tests.

                                                  * * * * * * *
Sec.   63.8(f)(1)-(5)..............  Alternative Monitoring  Yes........................  ......................
                                      Procedure.

                                                  * * * * * * *
Sec.   63.10(a), (b)(1), (d)(1),     Recordkeeping and       Yes........................  ......................
 (d)(4), (e)(3), (f).                 Reporting
                                      Requirements.

                                                  * * * * * * *
Sec.   63.10(b)(2)(i), (ii), (iv),   Recordkeeping for       No, for new or               See Sec.   63.9545 for
 (v).                                 Startup, Shutdown and   reconstructed sources        recordkeeping
                                      Malfunction.            which commenced              requirements.
                                                              construction or
                                                              reconstruction after May
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before [DATE 181 DAYS
                                                              AFTER PUBLICATION OF FINAL
                                                              RULE IN THE Federal
                                                              Register], and
                                                             No thereafter..............
Sec.   63.10(b)(2)(iii), (vi)-(xiv)  Owner/Operator          Yes........................  ......................
                                      Recordkeeping
                                      Requirements.

                                                  * * * * * * *
Sec.   63.10(d)(5).................  SSM reports...........  No, for new or               See Sec.   63.9540 for
                                                              reconstructed sources        malfunction reporting
                                                              which commenced              requirements.
                                                              construction or
                                                              reconstruction after May
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before [DATE 181 DAYS
                                                              AFTER PUBLICATION OF FINAL
                                                              RULE IN THE Federal
                                                              Register], and
                                                             No thereafter..............

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-09200 Filed 5-2-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 38 (Friday, February 25, 2022)]
[Rules and Regulations]
[Pages 10712-10714]
[FR Doc No: 2022-04098]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0149; Project Identifier MCAI-2022-00121-Q;
Amendment 39-21960; AD 2022-05-09]
RIN 2120-AA64

Airworthiness Directives; MARS A.S. Parachutes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain MARS A.S. emergency parachutes. This AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI identifies the unsafe
condition as the length of the ripcord between the pins being too long,
which could cause a malfunction of the emergency parachute. This AD
requires removing emergency parachutes with certain manufacture dates
or serial numbers from service. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective March 14, 2022.
    The FAA must receive comments on this AD by April 11, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact MarS a.s.,
Okru[zcaron]n[iacute] II 239, 569 43 Jev[iacute][ccaron]ko, Czech
Republic; phone: +420 461 353 841; email: [email protected]; website:
https://www.marsjev.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0149; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
MCAI, any comments received, and other information. The street address
for the Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Darren Gassetto, COS Program Manager,
Boston ACO Branch, Compliance & Airworthiness Division, FAA, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA Emergency AD 2022-0018-E, dated January 28, 2022 (referred to
after this as ``the MCAI''), to address an unsafe condition on certain
MARS A.S. ATL-88/90-1B (commercially known as ATL-15 SL) emergency
parachutes. The MCAI states:

    During the yearly inspection of one of the affected emergency
parachutes, it has been found that the length of the ripcord between
the pins was too large and, in some cases, only one of 2 loops of
the parachute could be opened when the manual ripcord was pulled.
Subsequent inspection revealed that the dimensions of the static
line extension were out of production tolerances. It is expected
that the manufacturer will develop a modification to restore the
airworthiness of affected emergency parachutes.
    This condition, if not corrected, could cause a malfunction of
the emergency parachute.
    To address this unsafe condition EASA issued Emergency AD 2022-
0017-E to require removal from service of the affected emergency
parachutes.
    Since that [EASA] AD was issued, it was determined that the
Applicability of that [EASA] AD was incorrect.
    For the reasons described above, this [EASA] AD retains the
requirements of EASA Emergency AD 2022-0017-E, which is superseded,
but with a different Applicability.
    This [EASA] AD is considered to be an interim measure and
further [EASA] AD action may follow.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0149.

Related Service Information

    The FAA reviewed MarS a.s. letter titled ``Information for dealers
and users of the ATL-15 SL emergency parachute (ATL-88/90-1B),'' dated
January 27, 2022. This letter provides information for identifying and
suspending the use of affected emergency parachutes, which have an
extension of static line made of Microline cord that was manufactured
outside of production tolerances.

AD Requirements

    This AD applies to emergency parachutes with certain manufacture
dates or serial numbers and requires removing those emergency
parachutes from service.

Differences Between This AD and the MCAI

    The MCAI requires storing emergency parachutes in the unrigged
condition in storage containers and visibly mark those storage
containers with the words ``Parachute not airworthy. Do not use until
further notice,'' while this AD requires removing the emergency
parachutes from service.
    This AD also requires removing from service any emergency parachute
where the serial number or manufacture date is unknown, and the MCAI
does not include that requirement.

Interim Action

    The FAA considers this AD to be an interim action. If final action
is later identified, the FAA might consider further rulemaking then.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because failure of an emergency parachute to deploy when needed will
lead to the parachutist freefalling to the surface without being
slowed, resulting in serious injury or death. Thus, the affected
parachutes must be removed from service as of the effective date of
this AD. Accordingly, notice and opportunity for prior public comment
are impracticable and contrary to the public interest pursuant to 5
U.S.C. 553(b)(3)(B).
    The FAA has also found that the risk to the flying public justifies
foregoing notice and comment prior to adoption of this rule because
there are no affected emergency parachutes used in the United States
and thus, it is unlikely that the FAA will receive any adverse comments
or useful information about this AD from U.S. operators. Accordingly,
notice and opportunity for prior public comment are unnecessary
pursuant to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forego notice and
comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-0149 and Project Identifier
MCAI-2022-00121-Q'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, 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 final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

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 AD 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 AD, 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 AD. Submissions containing CBI should be sent Darren
Gassetto, COS Program Manager, Boston ACO Branch, Compliance &
Airworthiness Division, FAA, 1200 District Avenue, Burlington, MA
01803. Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD does not affect any emergency
parachutes used in the United States. According to the manufacturer,
none of the affected emergency parachutes were sold through its
distributors in the United States. In the event an affected emergency
parachute is brought into the United States, the following is an
estimate of the costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                 Action                           Labor cost                  Parts cost              product
----------------------------------------------------------------------------------------------------------------
Remove emergency parachute from service.  0.5 work-hour x $85.00 per  Not Applicable............          $42.50
                                           hour = $42.50.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2022-05-09 MARS A.S.: Amendment 39-21960; Docket No. FAA-2022-0149;
Project Identifier MCAI-2022-00121-Q.

(a) Effective Date

    This airworthiness directive (AD) is effective March 14, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to MARS A.S. ATL-88/90-1B (commercially known as
ATL-15 SL) emergency parachutes with an extension of static line
made of Microline cord and that meet any of the criterion in
paragraph (c)(1), (2), or (3) of this AD:
    (1) The parachute has a date of manufacture between January 1,
2016, and December 31, 2020, inclusive;
    (2) The parachute has a serial number (S/N) 2145001 through S/N
2145005 inclusive, and S/N 2145023 through S/N 2145034 inclusive; or
    (3) The date of manufacture or the S/N of the parachute is
unknown.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2563, Parachute.

(e) Unsafe Condition

    This AD results from mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI identifies the unsafe condition as the length of
the ripcord between the pins being too long, which could cause a
malfunction of the emergency parachute. The unsafe condition, if not
addressed, could result in failure of the emergency parachute to
deploy when needed.

(f) Compliance

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

(g) Remove From Service

    As of the effective date of this AD, remove each emergency
parachute from service.

(h) Special Flight Permit

    Special flight permits are prohibited.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (j)(1) of this AD and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Darren Gassetto,
COS Program Manager, Boston ACO Branch, Compliance & Airworthiness
Division, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(516) 228-7323; email: [email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA)
Emergency AD 2022-0018-E, dated January 28, 2022, for more
information. You may examine the EASA AD in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0149.

(k) Material Incorporated by Reference

    None.

    Issued on February 18, 2022.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-04098 Filed 2-23-22; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register: June 2, 2006 (Volume 71, Number 106)]
[Notices]
[Page 32077]
[DOCID:fr02jn06-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Amendment of Exemption and Soliciting
Comments, Motions To Intervene, and Protests

May 25, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment to exemption; Change in mode of
operation from store-and-release to run-of-river.
    b. Project No: 7253-008.
    c. Date Filed: January 24, 2006.
    d. Applicant: Swift River Company.
    e. Name of Project: Sebec Hydro.
    f. Location: The Sebec Hydro Project (FERC No. 7253) is located on
the Sebec River near the town of Sebec in Piscataquis County, Maine.
    g. Filed Pursuant to: Federal Power Act, 18 CFR 4.104.
    h. Applicant Contact: Mr. Peter Clark, President, Swift River
Company, P.O. Box 149A, Hamilton, MA 01936--0149, Phone: (508) 468-
3999, Fax:<PHONE_NUMBER>.
    i. FERC Contact: Any questions regarding this notice should be
addressed to Brandi Sangunett at<PHONE_NUMBER> or e-mail at:
<EMAIL_ADDRESS>
    j. Description of Request: Sebec hydro requests to amend its
exemption by changing the project's mode of operation from store-and-
release to run-of-river. The exemptee proposes to install a lake level
control system at the project to maintain a minimum flow of 40 cubic
feet per second (cfs) and to maintain the reservoir elevation within 6
inches of full elevation (332.8 feet and 322.3 feet). The exemptee
would continue to drawn down lake levels in winter to 317.8 feet on or
before March 31, and release a minimum flow of 40 cfs.
    k. Deadline for Filing Comments or Motions: June 26, 2006.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426 or may be viewed on the Commission's Web site at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
``h'' above.
    m. Anyone may submit responses in accordance with the requirements
of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In
determining the appropriate action to take, the Commission will
consider all protests or other comments filed, but only those who file
a motion to intervene in accordance with the Commission's Rules may
become a party to the proceeding. Any responses must be received on or
before the specified comment date for the particular application.
    n. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the project number (P-7253-008) to which the filing
refers. All documents (original and eight copies) should be filed with:
The Secretary, Federal Energy Regulatory Commission, 888 First Street,
NE., Washington, DC 20426. A copy of any motion to intervene must also
be served upon each representative of the Applicant specified in the
particular application.
    o. Comments, protests, and interventions may be filed
electronically via the Internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages e-
filings. Federal, State, and local agencies are invited to file
comments on the described applications. A copy of the applications may
be obtained by agencies directly from the Applicant. If an agency does
not file comments within the time specified for filing comments, that
agency will be presumed to have no comments. One copy of an agency's
comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E6-8522 Filed 6-1-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68627-68628]
[FR Doc No: 2023-21984]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3329]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held virtually on November 16, 2023, from 9
a.m. to 1:30 p.m. eastern time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform.
    Answers to commonly asked questions about FDA advisory committee
meetings, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-3329. The docket will close on November
15, 2023. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. eastern time at the end of
November 15, 2023. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
    Comments received on or before November 1, 2023, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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-2023-N-3329 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.'' FDA 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 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 the 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>.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2894, email: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online

teleconferencing and/or video conferencing platform.
    The Committee will receive updates on the accelerated approval
program in oncology and two new drug applications (NDAs) approved under
21 CFR 314.500 (subpart H, accelerated approval regulations) that have
not met their agreed-upon milestones for completion of confirmatory
trial(s). Confirmatory trials are postmarketing studies to verify and
describe the clinical benefit of a drug after it receives accelerated
approval. These updates will provide information on the status of all
accelerated approvals granted in oncology, including products with
delayed confirmatory trials, and the status of confirmatory trials for
the specific NDAs to be discussed, including any ongoing and planned
trials.
    The two products to be discussed are: (1) FOLOTYN (pralatrexate),
NDA 022468 submitted by Acrotech Biopharma Inc, indicated for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma (PTCL), and (2) BELEODAQ (belinostat), NDA 206256 submitted by
Acrotech Biopharma Inc, indicated for the treatment of patients with
relapsed or refractory PTCL. Based on the updates provided, the
Committee will have a general discussion about delayed confirmatory
trials as well as a focused discussion on next steps for the two
products, FOLOTYN (pralatrexate) and BELEODAQ (belinostat), approved
for PTCL. The overall goal will be the continued optimization of the
accelerated approval process with a focus on decreasing the amount of
time to verify (or fail to verify) clinical benefit, while continuing
to provide early availability of promising oncology products.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before November 1, 2023, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
11:30 a.m. and 12:30 p.m. eastern time. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 24, 2023. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 25, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Moon Hee V. Choi (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and the ends of justice will be served by
allowing for this modification to FDA's advisory committee meeting
procedures.

    Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21984 Filed 10-3-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62128-62130]
[FR Doc No: 2011-25861]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65459; File No. SR-FINRA-2011-053]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change to Amend
Certain Trade Reporting and Compliance Rules

September 30, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 22, 2011, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by FINRA.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    FINRA is proposing to amend FINRA Rule 6730 regarding reporting a
transaction in a TRACE-Eligible Security, other than a transaction in
an Asset-Backed Security, on a non-business day, and reporting size
(volume), commission and settlement, in order for FINRA to consolidate
all TRACE-Eligible Securities transaction processing and data
management on a single technology platform, the Multi Product Platform
(``MPP'').
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, on the
Commission's Web site at http://www.sec.gov, and at the Commission's
Public Reference Room.

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

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

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

1. Purpose
    Currently, TRACE-Eligible Securities that are Asset-Backed
Securities are processed on FINRA's enhanced technology platform,
MPP.\3\ FINRA proposes certain amendments to the reporting requirements
of Rule 6730 of the Trade Reporting and Compliance Engine (TRACE) rules
that will permit FINRA to migrate all other TRACE-Eligible Securities
to MPP. The proposed amendments are substantially similar to
requirements that currently apply to transactions in Asset-Backed
Securities, and will simplify reporting a

transaction executed on a holiday or a weekend, the size of a
transaction, commission, if charged, and settlement.
---------------------------------------------------------------------------

    \3\ ``TRACE-Eligible Security'' and ``Asset-Backed Security''
are defined in, respectively, Rule 6710(a) and Rule 6710(m).
---------------------------------------------------------------------------

    FINRA believes that the proposed consolidation of all TRACE-
Eligible Securities on MPP will improve TRACE reporting and provide
several benefits to broker-dealers. First, the MPP program incorporates
more current industry standards, conventions and terms, and the
proposed amendments to Rule 6730 to incorporate those standards will
clarify and simplify the reporting requirements, and reduce reporting
errors and costs. For example, when quoting, trading and recording
positions in books and records, generally, the size (volume) of a
transaction or a position is stated as the total par or principal
value, which is how size (volume) of a TRACE transaction would be
reported on MPP.\4\ The proposed amendments should reduce the
incidences of data ``translations'' made by a broker-dealer when
transaction data is both recorded in internal firm systems and reported
to TRACE, and therefore should reduce operational complexities and
reporting errors and fees, improve compliance, and reduce system-
related costs. Second, MPP will provide broker-dealers a wider range of
options for reporting, most notably providing support for the Financial
Information eXchange (``FIX'') protocol. Third, MPP provides enhanced
functionality for the management of TRACE data. Broker-dealers will be
able to access TRACE-Eligible Securities data with greater ease and
more quickly, including obtaining real-time intra-day data changes or
additions. Fourth, standardizing most of the reporting requirements for
TRACE-Eligible Securities and consolidating all TRACE-Eligible
Securities on a single improved platform will allow broker-dealers to
maintain one interface for all TRACE reporting, which should permit
broker-dealers to reduce the operational complexity of reporting,
improve the accuracy overall of their TRACE reporting, and eliminate
costs associated with maintaining multiple technology platforms.
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    \4\ Similarly, the proposed change in Rule 6730 regarding
settlement, which would require reporting of the actual date of
settlement and delete the use of modifiers that are required
currently in many instances, may simplify reporting settlement.
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    The proposed amendments to Rule 6730 regarding reporting a
transaction executed on a holiday or a weekend, the size (volume) of a
transaction, commission, if charged, and settlement are discussed
below. In addition, the proposed rule change includes minor
administrative, technical and clarifying changes.
TRACE-Eligible Securities Transactions Executed on a Non-Business Day
    Currently, as set forth in Rule 6730(a)(1)(D) and Rule
6730(a)(2)(B), transactions in TRACE-Eligible Securities, except Asset-
Backed Securities, that are executed on a weekend, holiday or other day
when the TRACE system is not open must be reported the next business
day (T + 1), designated ``as/of,'' and are subject to two unique
requirements. First, the date of execution (``Trade Date'') reported to
TRACE is not the actual date the trade was executed; instead, a member
must report as the Trade Date the day (i.e., T + 1) that the report
must be timely submitted. Second, the execution time reported must be
``12:01:00 a.m. Eastern Time'' (``00:01:00''), instead of the actual
Time of Execution.\5\ The two requirements were established at the
inception of TRACE because, at that time, the TRACE system did not
recognize any day on which the TRACE system is closed as a valid Trade
Date, and the two requirements allow FINRA to distinguish transactions
in TRACE-Eligible Securities executed on non-business days from all
other reported transactions.
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    \5\ ``Time of Execution'' is defined in Rule 6710(d). Also, when
the reporting method used includes a ``special price memo'' field,
the member must enter the actual date of execution and Time of
Execution in such field.
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    FINRA has enhanced the TRACE system to recognize, for all types of
TRACE-Eligible Securities, any calendar date as a valid Trade Date.\6\
Accordingly, FINRA proposes to amend Rule 6730(a)(1)(D) and Rule
6730(a)(2)(B) to delete in both provisions the two unique requirements,
which are no longer necessary, and to require members to report
transactions executed on non-business days in the same manner that
transactions executed after or before TRACE System Hours on business
days are reported currently.\7\ FINRA also proposes to combine Rule
6730(a)(1)(B) and Rule 6730(a)(1)(D) as renumbered amended Rule
6730(a)(1)(D), and delete current Rule 6730(a)(1)(B). In addition,
FINRA proposes to reorganize the reporting requirements in Rule
6730(a)(1)(A) through Rule 6730(a)(1)(C) in chronological order and to
incorporate minor technical changes.\8\
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    \6\ Previously, FINRA modified the TRACE system to recognize any
calendar date as a valid Trade Date, but only as to transactions in
Asset-Backed Securities. (See Securities Exchange Act Release No.
64364 (April 28, 2011), 76 FR 25385 (May 4, 2011) (order approving
File No. SR-FINRA-2011-012).) The rule changes became effective on
May 16, 2011. (See Regulatory Notice 11-20 (May 2011).)
    \7\ ``TRACE System Hours'' is defined in Rule 6710(t).
    \8\ The reporting requirements now set forth in Rule
6730(a)(1)(C) will be set forth in Rule 6730(a)(1)(A), and Rule
6730(a)(1)(A) will be renumbered as Rule 6730(a)(1)(B), except the
requirement relating to transactions executed less than 15 minutes
before the TRACE System closes will be set forth separately as Rule
6730(a)(1)(C).
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Size (Volume), Commission and Settlement Terms
    FINRA also proposes amendments to the technical requirements for
reporting the size (volume) of a transaction, the commission, if any,
and the settlement of transactions in TRACE-Eligible Securities, other
than Asset-Backed Securities.
    Currently, FINRA requires members to report the size (volume) of a
transaction in a TRACE-Eligible Security, other than an Asset-Backed
Security, by reporting the number of bonds.\9\ For example, a sale of
corporate bonds or Agency Debt Securities having a par or principal
value of $10,000 is reported as a sale of 10 bonds.\10\ FINRA proposes
to amend Rule 6730(c)(2) and Rule 6730(d)(2) to require a member to
report the size of such transactions using the total par value or
principal value traded, rather than the number of bonds.\11\
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    \9\ See Rule 6730(c)(2) and Rule 6730(d)(2).
    \10\ ``Agency Debt Security'' is defined in Rule 6710(l).
    \11\ Previously, FINRA adopted similar provisions for reporting
the size (volume) of transactions in Asset-Backed Securities that do
not amortize. (See Securities Exchange Act Release No. 61566
(February 22, 2010), 75 FR 9262 (March 1, 2010) (order approving
File No. SR-FINRA-2009-065).) The rule changes became effective on
May 16, 2011. (See Regulatory Notice 11-20 (May 2011).)
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    FINRA proposes a similar change to the reporting of commissions.
Under current Rule 6730(c)(11) and Rule 6730(d)(1), in those cases
where a commission is charged in a transaction in a TRACE-Eligible
Security, the commission must be reported ``stated in points per bond
(e.g., for corporate bonds, 1 point equals $10.00 per bond).'' \12\
FINRA proposes to amend Rule 6730(c)(11) and Rule 6730(d)(1) to require
members to report the total dollar amount of the commission, rather
than the points per bond.\13\
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    \12\ Rule 6730(d)(1).
    \13\ Previously, FINRA adopted similar provisions for reporting
a commission in a transaction in an Asset-Backed Security. (See
Securities Exchange Act Release No. 61566 (February 22, 2010), 75 FR
9262 (March 1, 2010) (order approving File No. SR-FINRA-2009-065).)
The rule changes became effective on May 16, 2011. (See Regulatory
Notice 11-20 (May 2011).)
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    FINRA also proposes to simplify the requirements for reporting the
settlement of a TRACE-Eligible Security transaction. Currently, as
provided in Rule 6730(d)(4)(B)(i), if a transaction,

other than a transaction in an Asset-Backed Security, will not settle
on T + 3, a member must report the settlement using one of three
modifiers.\14\ To streamline the requirements regarding settlement, new
Rule 6730(c)(12) will require a member simply to report the date of
settlement.\15\ In addition, FINRA proposes to delete Rule
6730(d)(4)(B), which sets forth the three settlement modifiers that
will no longer be used in TRACE reporting, and references to such
modifiers in Rule 6730(d)(4)(C). FINRA also will renumber Rule
6730(d)(4)(C), Rule 6730(d)(4)(D) and Rule 6730(d)(4)(E)
accordingly.\16\
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    \14\ Current Rule 6730(c)(12) will be renumbered as Rule
6730(c)(13). If a trade will not settle on T + 3, the three
modifiers that are used to indicate the day the transaction will be
settled are ``.c'' (date of execution), ``.nd'' (T + 1), or ``.sNN''
(settlement on a date other than the date of execution, T + 1 or T +
3).
    \15\ Previously, FINRA adopted a similar requirement in
connection with transactions in Asset-Backed Securities. (See
Securities Exchange Act Release No. 61566 (February 22, 2010), 75 FR
9262 (March 1, 2010) (order approving File No. SR-FINRA-2009-065)
and Securities Exchange Act Release No. 64364 (April 28, 2011), 76
FR 25385 (May 4, 2011) (order approving File No. SR-FINRA-2011-
012)). The rule changes in both rule filings became effective on May
16, 2011. (See Regulatory Notice 11-20 (May 2011).)
    \16\ Rule 6730(d)(4)(C), Rule 6730(d)(4)(D) and Rule
6730(d)(4)(E) will be renumbered, respectively, as Rule
6730(d)(4)(B), Rule 6730(d)(4)(C) and Rule 6730(d)(4)(D).
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    Finally, FINRA proposes minor technical amendments to Rule 6730(a)
through (d), including amendments to Rule 6730(b)(2) and Rule
6730(c)(7) to delete redundant or unnecessary text and Rule 6730(d)(2)
to clarify existing text.
    FINRA will announce the effective date of the proposed rule change
in a Regulatory Notice to be published no later than 60 days following
Commission approval. The effective date will be no later than 180 days
following publication of the Regulatory Notice announcing Commission
approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\17\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
facilitate more timely and accurate reporting of the terms of
transactions in TRACE-Eligible Securities for the protection of
investors and in furtherance of the public interest.
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    \17\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission shall:
(a) By order approve or disapprove such proposed rule change, or (b)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-053 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-053. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing will also be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File No. SR-FINRA-2011-053
and should be submitted on or before October 27, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Elizabeth M. Murphy,
Secretary.
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    \18\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2011-25861 Filed 10-5-11; 8:45 am]
BILLING CODE 8011-01-P