[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11783-11786]
[FR Doc No: 2011-4474]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0265] (formerly Docket 2007N-0026)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Canning
Establishment Registration, Process Filing, and Recordkeeping for
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically
Sealed Containers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by April
4, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0037.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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

Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers--(OMB Control Number 0910-
0037)--Revision

    Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA
is authorized to prevent the interstate distribution of food products
that may be injurious to health or that are otherwise adulterated, as
defined in section 402 of the FD&C Act (21 U.S.C. 342). Under the
authority granted to FDA by section 404 of the FD&C Act (21 U.S.C.
344), FDA regulations require registration of food processing
establishments, filing of process or other data, and maintenance of
processing and production records for acidified foods and thermally
processed low-acid foods in hermetically sealed containers. These
requirements are intended to ensure safe manufacturing, processing, and
packing procedures and to permit FDA to verify that these procedures
are being followed. Improperly processed low-acid foods present life-
threatening hazards if contaminated with foodborne microorganisms,
especially Clostridium botulinum. The spores of C. botulinum must be
destroyed or inhibited to avoid production of the deadly toxin that
causes botulism. This is accomplished with good manufacturing
procedures, which must include the use of adequate heat processes or
other means of preservation.
    To protect the public health, FDA regulations require that each
firm that manufactures, processes, or packs acidified foods or
thermally processed low-acid foods in hermetically sealed containers
for introduction into interstate commerce register the establishment
with FDA using Form FDA 2541 (Sec. Sec.  108.25(c)(1) and 108.35(c)(1)
(21 CFR 108.25(c)(1) and 108.35(c)(1))). In addition to registering the
plant, each firm is required to provide data on the processes used to
produce these foods, using Form FDA 2541a for all methods except
aseptic processing, or Form FDA 2541c for aseptic processing of low-
acid foods in hermetically sealed containers (Sec. Sec.  108.25(c)(2)
and 108.35(c)(2)). Plant registration and process filing may be
accomplished simultaneously. Process data must be filed prior to
packing any new product (Sec. Sec.  108.25(c)(2) and 108.35(c)(2)). For
processors of thermally processed low-acid foods in hermetically sealed
containers, operating processes and procedures must be posted near the
processing equipment or made available to the operator (Sec.  113.87(a)
(21 CFR 113.87(a))).
    Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and
114) require firms to maintain records showing adherence to the
substantive requirements of the regulations. These records must be made
available to FDA on request. Firms are also required to document
corrective actions when process controls and procedures do not fall
within specified limits (Sec. Sec.  113.89, 114.89, and 114.100(c)); to
report any instance of potential health-endangering spoilage, process
deviation, or contamination with microorganisms where any lot of the
food has entered distribution in commerce (Sec.  108.25(d) and Sec.
108.35(d) and (e)); and to develop and keep on file plans for recalling
products that may endanger the public health (Sec. Sec.  108.25(e) and
108.35(f)). To permit lots to be traced after distribution, acidified
foods and thermally processed low-acid foods in hermetically sealed
containers must be marked with an identifying code (Sec. Sec.
113.60(c) (thermally processed foods) and 114.80(b) (acidified foods)).
    These collection of information provisions are currently approved
under OMB control number 0910-0037 (expires August 31, 2011). In the
Federal Register of March 14, 2007 (72 FR 11990), FDA published a
proposed rule entitled ``Temperature-Indicating Devices; Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers''
(the proposed rule). This document proposed to revise FDA's regulations
for thermally processed low-acid foods in part 113 to, among other
things, provide for the use of temperature-indicating devices other
than mercury-in-glass thermometers during processing, require that
temperature-indicating devices be tested for accuracy against a
calibrated reference device, and to establish recordkeeping
requirements for temperature-indicating devices and reference devices
maintained by the processor. In compliance with the PRA (44 U.S.C.
3506(c)(2)(B)), the Agency requested public comment on the information
collection provisions of the proposed rule (72 FR 11990 at 12004).
    Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule entitled ``Temperature-Indicating Devices; Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers''
(the final rule). The final rule revises the information collection
currently approved under OMB control number 0910-0037 by adding
recordkeeping requirements in new Sec.  113.100(c) and (d). The
information to be recorded under these regulations is related to
accuracy tests of temperature-indicating devices and reference devices
maintained by processors of low-acid canned foods. These tests must be
performed to ensure the accuracy of the devices during the processing
of these foods. If these devices are not accurate, the processor cannot
ensure that the low-acid canned foods it produces are safe to eat, and
consumers may be harmed. The recordkeeping requirements of the final
rule are necessary to document that appropriate accuracy tests have
been performed with the appropriate frequencies for each temperature-
indicating device and each reference device maintained by the
processor. Records of accuracy tests for these devices also help
processors determine how frequently the devices should be tested for
accuracy. Much of the information is currently generated for accuracy
tests performed under current regulations. However, the information may
not be recorded as required under the final rule.
    Current low-acid canned food regulations recommend, but do not
require, that processors keep records of accuracy tests for mercury-in-
glass thermometers, including test date, standard used, method used,
and person performing the test. The final rule requires processors to
keep records documenting the accuracy of temperature-indicating devices
(including but not limited to mercury-in-glass thermometers) and of
reference devices that are maintained by the processor. These records
include the

identifier of the device being tested, such as its tag or seal; the
name of the manufacturer of the device; the identity of the reference
device, equipment, and procedures used for the accuracy test and to
adjust the device or, if an outside facility conducts the accuracy
test, documentation regarding the traceability of the accuracy to a
National Institute of Standards and Technology or other national
metrology institute standard; the identity of the person or facility
that performed the accuracy test and adjusted or calibrated the device;
the date and results of each accuracy test, including the amount of
adjustment; and the date on or before which the next accuracy test must
be performed.
    In addition to requesting public comment on the new recordkeeping
provisions, the proposed rule also stated that FDA had submitted the
recordkeeping provisions to OMB for review (72 FR 11990 at 12005).
However, due to an administrative error, the Agency did not actually do
so, and, therefore, FDA is submitting them to OMB now. Because OMB
approval for the collections of information in the regulations the
final rule amends is set to expire on August 31, 2011, FDA is also
submitting those collections (as revised by the final rule) for OMB
review, along with the others currently approved under OMB control
number 0910-0037.
    Description of Respondents: The respondents to this information
collection are commercial processors and packers of acidified foods and
thermally processed low-acid foods in hermetically sealed containers.
    FDA estimates the burden of this information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
              Form No.                          21 CFR section               Number of     frequency per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541 (Registration)........  108.25 and 108.35.................             515            1                515            .17               88
Form FDA 2541a (Process Filing).....  108.25 and 108.35.................           1,489            8.62          12,835            .333           4,274
Form FDA 2541c (Process Filing).....  108.35............................              84            7.77             653            .75              490
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  ..................................  ..............  ..............  ..............  ..............           4,852
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimates of the number of respondents and the hours
per response on its experience with registration and process filing and
on information from industry. FDA estimates the total burden of
registration under Sec. Sec.  108.25 and 108.35 to be 88 hours (515
respondents x 1 annual response x 0.17 hours = 87.55 hours, rounded to
88 hours). FDA estimates the total burden of process filing on Form FDA
2541a under Sec. Sec.  108.25 and 108.35 to be 4,274 hours (1,489
respondents x 8.62 annual responses x 0.333 hours = 4,274.12 hours,
rounded to 4,274 hours). FDA estimates the total burden of process
filing on Form FDA 2541c under Sec.  108.35 to be 490 hours (84
respondents x 7.77 annual responses x 0.75 hours = 489.51 hours,
rounded to 490 hours). The reporting burden for Sec.  108.25(d) and
Sec.  108.35(d) and (e) is minimal because notification of spoilage,
process deviation, or contamination of product in distribution occurs
less than once per year. Most firms discover these problems before the
product is distributed and, therefore, are not required to report the
occurrence. To avoid double-counting, estimates for Sec. Sec.
108.25(g) and 108.35(h) have not been included because they merely
cross-reference recordkeeping requirements contained in parts 113 and
114.
    FDA permits electronic registration and filing on the Internet. The
electronic submission capability of the Low Acid Canned Food (LACF)
Program entitled eLACF was the second major registration application to
be supported by and integrated under the FDA Unified Registration and
Listing System (FURLs). Food canning establishments can request an
electronic account by sending an e-mail to<EMAIL_ADDRESS>
                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
       21 CFR part/section           Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
21 CFR Parts 113 and 114........           9,500               1           9,500             250       2,375,000
Burden added by new Sec.                   4,225              15          63,375          0.0097             615
 113.100(c) and (d).............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,375,615
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA received six letters, each containing one or more comments on
the proposed rule. Although the Agency did not identify any comments
referring specifically to the PRA, several comments discussed the
proposed recordkeeping provisions. FDA has summarized and responded to
these comments in section II of the final rule (Comments 1, 4, 11
through 13, and 18). None of the comments on the proposed rule
suggested that we modify our burden estimates for the new information
collection provisions. Thus, we have not changed our estimates of the
annual frequency per recordkeeping or the hours per record. We have,
however, increased the estimated number of recordkeepers to reflect
growth in the low-acid canned food processing industry since the 2007
proposed rule.
    Currently, there are 9,491 active firms in the LACF database, which
encompasses processors of low-acid

canned food, processors of acidified food, and processors of both types
of food. Thus, we estimate the number of processors keeping records
under parts 113 and 114 to be 9,500, as shown in table 2, row 1 of this
document. In the final rule, we estimated that there are approximately
8,450 foreign and domestic low-acid canned food processing
establishments. This estimate, which does not encompass establishments
that process only acidified foods (because such processors are not
affected by the final rule), was based on data in the LACF database as
of September 2009. As discussed in the explanation of the recordkeeping
estimate for the final rule in the following paragraphs, our estimate
assumes that half of the LACF industry currently does not record all of
the device accuracy testing information that the final rule requires.
Thus, as shown in table 2, row 2 of this document, we estimate that
4,225 low-acid canned food manufacturers that are not currently keeping
the records that are required under the final rule will begin to keep
such records to comply with the final rule when it becomes effective.
    FDA bases its estimates of the number of recordkeepers and the
hours per record on its experience and on information from industry.
FDA estimates that it takes 250 hours per respondent to comply with the
recordkeeping requirements in parts 113 and 114. In table 2, row 1 of
this document, FDA estimates the total burden of recordkeeping under
parts 113 and 114 before the effective date of the final rule to be
2,375,000 hours (9,500 respondents x 250 hours = 2,375,000 hours).
Table 2, row 2 reports the average annual recordkeeping burden of the
final rule. The burden of the recordkeeping requirement of the final
rule consists of the set-up time required to design and establish a
form for recording the required information, and the additional hours
of labor needed to record the information. The set-up time required for
designing a new recordkeeping form is assumed to be minimal because we
estimate that only a few data elements required in the final rule are
currently unreported by some processors and that only small
modifications to a processor's recordkeeping form would be required to
accommodate the additional data elements.
    We estimate that the amount of time needed to comply with the
recordkeeping requirements of the final rule will be small because
current industry practice is to keep track of most, if not all, of this
information. Because current incentives to track accuracy of mercury-
in-glass thermometers may vary across the industry, however, some
information that is currently generated during accuracy tests may not
be recorded as required under the final rule. Thus, we assume there
will be a burden incurred from the final rule to record information
that is currently generated, but not recorded.
    We assume that half of the industry currently does not record all
of the device accuracy testing information that the final rule
requires. We further assume that current practice by these firms is to
leave unrecorded 1 to 4 separate pieces of information required under
the final rule, and that each piece of information takes between 10 and
15 seconds to record. Consequently, we estimate that half of all low-
acid canned food manufacturers will spend between 10 seconds and 1
minute (i.e., 1 x 10 seconds and 4 x 15 seconds) per device to record
information required in the final rule.
    Based on a survey conducted by FDA between 1992 and 1993 of
mercury-in-glass thermometer calibration in the low-acid canned food
industry, we estimate that low-acid food firms use an average of 10
temperature-indicating devices, including reference devices. We
estimate that 4,225 low-acid canned food manufacturers (half of the
industry) currently do not fully record the accuracy test results
required by the final rule. Because the regulations specify that each
device must be tested upon installation and at least once per year
thereafter, or more frequently if necessary to ensure accuracy, we
estimate that each device requires 1 to 2 tests per year (midpoint of
1.5 tests per year). We therefore estimate the annual frequency per
recordkeeping to be 15 (i.e., 10 devices x 1.5 tests per year). We
estimate the burden for recording the additional information to be
between 10 and 60 seconds per device (midpoint of 35 seconds or 0.0097
hours per device). Therefore, the estimated total annual burden in
hours for the recordkeeping requirements of the final rule is
approximately 615 hours (63,375 x 0.0097 = 614.7 hours, rounded to 615
hours). Thus, the final rule increases the total burden of this
information collection by approximately 0.3 percent, from 2,375,000
hours to 2,375,615 hours.

    Dated: February 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-4474 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Page 27943]
[FR Doc No: 2014-11162]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 22d-1. OMB Control No.: 3235-0310, SEC File No. 270-275.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``Paperwork Reduction Act'') (44 U.S.C. 3501-3520), the
Securities and Exchange Commission (the ``Commission'') has submitted
to the Office of Management and Budget (``OMB'') a request for
extension of the previously approved collection of information
discussed below.
    Rule 22d-1 (17 CFR 270.22d-1) under the Investment Company Act of
1940 (the ``1940 Act'') (15 U.S.C. 80a et seq.) provides registered
investment companies that issue redeemable securities (``funds'') an
exemption from section 22(d) of the 1940 Act (15 U.S.C. 80a-22(d)) to
the extent necessary to permit scheduled variations in or elimination
of the sales load on fund securities for particular classes of
investors or transactions, provided certain conditions are met. The
rule imposes an annual burden per series of a fund of approximately 15
minutes, so that the total annual burden for the approximately 4714
series of funds that might rely on the rule is estimated to be 1178.5
hours.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act. The estimate is based on
communications with industry representatives, and is not derived from a
comprehensive or even a representative survey or study.
    Responses will not be kept confidential. 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 public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Chief Information Officer,
Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street
NE., Washington, DC 20549 or send an email to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: May 9, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-11162 Filed 5-14-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Notices]
[Pages 52225-52226]
[FR Doc No: 2018-22436]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3090]

Hematologic Malignancies: Regulatory Considerations for Use of
Minimal Residual Disease in Development of Drug and Biological Products
for Treatment; Draft 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 draft guidance for industry entitled
``Hematologic Malignancies: Regulatory Considerations for Use of
Minimal Residual Disease in Development of Drug and Biological Products
for Treatment.'' This draft guidance is intended to assist sponsors
planning to use minimal residual disease (MRD) as a biomarker in
clinical trials conducted under an investigational new drug application
(IND) or to support marketing approval of drugs and biological products
for the treatment of specific hematologic malignancies.

DATES: Submit either electronic or written comments on the draft
guidance by December 17, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3090 for ``Hematologic Malignancies: Regulatory
Considerations for Use of Minimal Residual Disease in Development of
Drug and Biological Products for Treatment.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Nicole Gormley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2310, Silver Spring, MD 20993-0002, 240-
402-0210; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Hematologic Malignancies: Regulatory Considerations for Use
of Minimal Residual Disease in Development of Drug and Biological
Products for Treatment.'' This draft guidance is intended to assist
sponsors planning to use MRD as a biomarker in clinical trials
conducted under an IND or to support marketing approval of drugs and
biological products for the treatment of specific hematologic
malignancies.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA

on regulatory considerations for use of MRD in drug and biological
products in development for hematologic malignancies. 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 312 for submitting INDs has
been approved under OMB control number 0910-0014. The collection of
information in 21 CFR part 314 for the submission of new drug
applications has been approved under OMB control number 0910-0001. The
collection of information in the draft guidance for industry entitled
``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products'' (available at<EMAIL_ADDRESS>has been approved
under OMB control number 0910-0429. The submission of special protocol
assessments has been approved under OMB control number 0910-0470.
    The submission of biologics license applications has been approved
under OMB control number 0910-0338. The submission of investigational
device exemptions has been approved under OMB control number 0910-0078.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: October 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22436 Filed 10-15-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Proposed Rules]
[Pages 3470-3475]
[FR Doc No: 2022-01238]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1185; Project Identifier AD-2021-00339-E]
RIN 2120-AA64

Airworthiness Directives; Honeywell International, Inc. (Type
Certificate Previously Held by AlliedSignal, Inc. and Textron Lycoming)
Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2002-03-01, which applies to all Honeywell International, Inc.
(Honeywell) T53 model turboshaft engines. AD 2002-03-01 requires
initial and repetitive special vibration tests of the engine, and if
necessary replacement with a serviceable reduction gearbox assembly, or
a serviceable engine before further flight. Since the FAA issued AD
2002-03-01, the FAA received reports that two additional Honeywell
model turboshaft engines, not captured in AD 2002-03-01, are also
subject to

tachometer drive spur gear failures due to vibration loads. This
proposed AD would require initial and repetitive special vibration
tests of the engine and, depending on the results, replacement of
either the reduction gearbox assembly or the engine. 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 March 10,
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 NPRM, contact Honeywell
International, Inc., 111 South 34th Street, Phoenix, AZ 85034; phone:
(800) 601-3099; fax:<PHONE_NUMBER>; website: https://myaerospace.honeywell.com/wps/portal. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call (817)
222-5110.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1185; 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, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Jeffrey Chang, Aviation Safety
Engineer, Los Angeles ACO Branch, FAA, 3960 Paramount Boulevard,
Lakewood, CA 90712; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-1185; Project Identifier
AD-2021-00339-E'' 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
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact we receive about this proposed AD.

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
Jeffrey Chang, Aviation Safety Engineer, Los Angeles ACO Branch, FAA,
3960 Paramount Boulevard, Lakewood, CA 90712. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Background

    The FAA issued AD 2002-03-01, Amendment 39-12642 (67 FR 6857,
February 14, 2002) (AD 2002-03-01) for all Honeywell (formerly
AlliedSignal, Inc. and Textron Lycoming) T5311A, T5311B, T5313B,
T5317A, T5317B, and former military T53-L-11, T53-L-11A, T53-L-11B,
T53-L-11C, T53-L-11D, T53-L-11A S/SA, T53-L-13B, T53-L-13B S/SA, T53-L-
13B S/SB, and T53-L-703 model turboshaft engines. AD 2002-03-01 was
prompted by reports of tachometer drive spur gear failure, resulting in
potential engine overspeed, loss of power turbine speed (N2) instrument
panel indication, and hard landings. AD 2002-03-01 requires initial and
repetitive special vibration tests of the engine and, for engines that
fail the special vibration tests, replacement of the gearbox assembly
or engine before further flight. The agency issued AD 2002-03-01 to
prevent excessive vibrations produced by the reduction gearbox assembly
that could cause failure of the tachometer drive spur gear.

Actions Since AD 2002-03-01 Was Issued

    Since the FAA issued AD 2002-03-01, the FAA received reports that
Honeywell T5317A-1 and T5317BCV model turboshaft engines are subject to
the same unsafe condition identified in AD 2002-03-01, tachometer drive
spur gear failures due to vibration loads. These model turboshaft
engines were not included in the applicability of AD 2002-03-01. The
FAA and Honeywell determined that the Honeywell T5317A-1 engine model
was inadvertently left out of the applicability of AD 2002-03-01 and
the Honeywell T5317BCV engine model was introduced into production
after the publication of AD 2002-03-01.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed AlliedSignal Aerospace Service Bulletin (SB)
T5311A/B-0100, dated January 20, 2000. This SB specifies procedures for
performing a special vibration check on Honeywell T5311A and T5311B
model turboshaft engines.
    The FAA reviewed AlliedSignal Aerospace SB T5313B/17-0100, dated
November 19, 1999. This SB specifies procedures for performing a
special vibration check on Honeywell T5313B, T5317A, and T5317B model
turboshaft engines.
    The FAA reviewed Honeywell SB T53-0147, dated May 29, 2007. This SB
specifies procedures for performing a special vibration check on
Honeywell T5317A-1 model turboshaft engines.
    The FAA reviewed Honeywell Maintenance Manual Temporary Revision
(TR) No. 165, dated July 29, 2020. This TR specifies procedures for
performing a special vibration check on Honeywell T5313B, T5317A,
T5317A-1, T5317B, and T5317BCV model turboshaft engines.

    The FAA reviewed AlliedSignal Aerospace SB T53-L-11-0100, Revision
2, dated January 20, 2000. This SB specifies procedures for performing
a special vibration check on Honeywell T53-L-11, -11A, -11B, -11C, -
11D, and -11A S/SA model turboshaft engines.
    The FAA reviewed AlliedSignal Aerospace SB T53-L-13B-0100, Revision
2, dated May 11, 1999. This SB specifies procedures for performing a
special vibration check on Honeywell T53-L-13B, -13B S/SA, and -13B S/
SB model turboshaft engines.
    The FAA reviewed AlliedSignal Aerospace SB T53-L-703-0100, Revision
2, dated May 11, 1999. This SB specifies procedures for performing a
special vibration check on Honeywell T53-L-703 model turboshaft
engines.
    The Director of the Federal Register approved AlliedSignal
Aerospace SB T5313B/17-0100, dated November 19, 1999; AlliedSignal
Aerospace SB T53-L-13B-0100, Revision 2, dated May 11, 1999;
AlliedSignal Aerospace SB T53-L-703-0100, Revision 2, dated May 11,
1999; AlliedSignal Aerospace SB T5311A/B-0100, dated January 20, 2000;
and AlliedSignal Aerospace SB T53-L-11-0100, Revision 2, dated January
20, 2000, for incorporation by reference as of March 21, 2002 (67 FR
6857, February 14, 2002). This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in
ADDRESSES.

Other Related Service Information

    The FAA reviewed AlliedSignal Aerospace SB T5311/T53-L-11-0103,
dated January 20, 2000. This SB specifies procedures for replacing the
reduction gearbox assembly on Honeywell T5311A and T5311B model
turboshaft engines and Honeywell T53-L-11, -11A, -11B, -11C, -11D, and
-11A S/SA model turboshaft engines.
    The FAA reviewed AlliedSignal Aerospace SB T5313B/17-0103, dated
November 19, 1999. This SB specifies procedures for replacing the
reduction gearbox assembly on Honeywell T5313B, T5317A, and T5317B
model turboshaft engines.
    The FAA reviewed AlliedSignal Aerospace SB T53-L-13B-0103, Revision
4, dated November 2, 1999. This SB specifies procedures for replacing
the reduction gearbox assembly on Honeywell T53-L-13B, -13B S/SA, and -
13B S/SB model turboshaft engines.
    The FAA reviewed AlliedSignal Aerospace SB T53-L-703-0103, Revision
4, dated November 2, 1999. This SB specifies procedures for replacing
the reduction gearbox assembly on Honeywell T53-L-703 model turboshaft
engines.

Proposed AD Requirements in This NPRM

    This proposed AD would retain all of the requirements of AD 2002-
03-01. This proposed AD would require initial and repetitive special
vibration tests of the engine and, depending on the results,
replacement of either the reduction gearbox assembly or the engine.
This proposed AD would also expand the applicability to include
Honeywell T5317A-1 and T5317BCV model turboshaft engines.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 150 engines installed on helicopters of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Special vibration test of the engine..  4 work-hours x $85 per                $0            $340         $51,000
                                         hour = $340.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacement that would be required based on the results of the proposed
special vibration test. The agency has no way of determining the number
of aircraft that might need this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace the reduction gearbox assembly........  40 work-hours x $85 per hour =           $48,000         $51,400
                                                 $3,400.
Replace the engine............................  24 work-hours x $85 per hour =           250,577         252,617
                                                 $2,040.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the 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:
0
a. Removing Airworthiness Directive 2002-03-01, Amendment 39-12642 (67
FR 6857, February 14, 2002); and
0
b. Adding the following new airworthiness directive:

Honeywell International Inc. (Type Certificate previously held by
AlliedSignal, Inc. and Textron Lycoming): Docket No. FAA-2021-1185;
Project Identifier AD-2021-00339-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 10, 2022.

(b) Affected ADs

    This AD replaces AD 2002-03-01, Amendment 39-12642 (67 FR 6857,
February 14, 2002).

(c) Applicability

    This AD applies to Honeywell International, Inc. (Type
Certificate previously held by AlliedSignal, Inc. and Textron
Lycoming) T5311A, T5311B, T5313B, T5317A, T5317A-1, T5317B,
T5317BCV, and former military T53-L-11, T53-L-11A, T53-L-11B, T53-L-
11C, T53-L-11D, T53-L-11A S/SA, T53-L-13B, T53-L-13B S/SA, T53-L-13B
S/SB, and T53-L-703 model turboshaft engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7600, Engine
Controls.

(e) Unsafe Condition

    This AD was prompted by reports of tachometer drive spur gear
failure, resulting in potential engine overspeed, loss of power
turbine speed (N2) instrument panel indication, and hard landings.
The FAA is issuing this AD to prevent excessive vibrations produced
by the reduction gearbox assembly that could cause failure of the
tachometer drive spur gear. The unsafe condition, if not addressed,
could result in failure of the engine, loss of thrust control, and
damage to the aircraft.

(f) Compliance

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

(g) Required Actions

    (1) Within 100 flight hours (FHs) after the effective date of
this AD, perform an initial special vibration test of the engine
using the service information, as applicable to the engine model,
listed in Table 1 to paragraph (g)(1) of this AD.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TP24JA22.000

BILLING CODE 4910-13-C
    (2) Thereafter, within the following compliance times, perform
repetitive special vibration tests of the engine:
    (i) For engines that have tachometer drive spur gear part number
(P/N) 1-070-062-04 installed, perform a repetitive special vibration
test before exceeding 500 FHs since the last special vibration test.
    (ii) For engines that have tachometer drive spur gear P/N 1-070-
062-06 installed, perform a repetitive special vibration test before
exceeding 1,000 FHs since the last special vibration test.
    (3) If, during any special vibration test required by paragraph
(g)(1) or (2) of this AD, an engine exceeds the 0.2 inches per
second (IPS) limit for any peak RPM/frequency bands, perform one of
the following:
    (i) Before further flight, replace the reduction gearbox
assembly with a reduction gearbox assembly eligible for
installation; or
    (ii) Before further flight, replace the engine with an engine
eligible for installation.
    (4) After replacing the reduction gearbox assembly or engine, as
required by paragraph (3)(i) or (ii) of this AD, before further
flight, perform an initial special vibration test of the engine
using the service information, as applicable to the engine model,
listed in Table 1 to paragraph (g)(1) of this AD.
    (5) If, during the special vibration test required by paragraph
(g)(4) of this AD, an engine exceeds the 0.2 IPS limit for any peak
within the RPM/frequency bands, before further flight, replace the
reduction gearbox assembly or the engine.

(h) Definitions

    (1) For the purpose of this AD, a ``reduction gearbox assembly
eligible for installation'' is a new, zero hour reduction gearbox
assembly or an overhauled reduction gearbox assembly with tachometer
drive spur gear P/N 1-070-062-04 or P/N 1-070-062-06 that does not
exceed the 0.2 IPS limit for any peak within the RPM/frequency bands
during the administered special vibration test.
    (2) For the purpose of this AD, an ``engine eligible for
installation'' is an engine with tachometer drive spur gear P/N 1-
070-062-04 or P/N 1-070-062-06 that does not exceed the 0.2 IPS
limit for any peak within the RPM/frequency bands during the
administered special vibration test.

(i) No Reporting Requirement

    The reporting requirements in the Accomplishment Instructions,
paragraph 3.A. or paragraph 11.F, of the service information, as
applicable to the engine model, listed in Table 1 to paragraph
(g)(1) of this AD, are not required by this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles 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
(k)(1) of this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) AMOCs approved for AD 2002-03-01 (67 FR 6857, February 14,
2002) are approved as AMOCs for the corresponding provisions of this
AD.

(k) Related Information

    (1) For more information about this AD, contact Jeffrey Chang,
Aviation Safety Engineer, Los Angeles ACO Branch, FAA, 3960
Paramount Boulevard, Lakewood, CA 90712; phone:<PHONE_NUMBER>; fax:
(562) 627-5210; email: [email protected].
    (2) For service information identified in this AD, contact
Honeywell International, Inc., 111 South 34th Street, Phoenix, AZ
85034; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; website: https://myaerospace.honeywell.com/wps/portal. You may view this referenced
service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

    Issued on January 18, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-01238 Filed 1-21-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 45 (Wednesday, March 8, 2023)]
[Notices]
[Pages 14439-14440]
[FR Doc No: 2023-04720]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket Nos. FMCSA-2016-0102 and FMCSA-2022-0134]

Property Broker Listening Session; Public Meeting

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

ACTION: Notice of public listening session.

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

SUMMARY: FMCSA announces that it will host a listening session
pertaining to property brokers. Specifically, the Agency would like to
hear from members of the public on two matters relating to the
regulation of property brokers: (1) a January 5, 2023 notice of
proposed rulemaking (NPRM) proposing to regulate five separate areas of
broker (and freight forwarder) financial responsibility: assets readily
available; immediate suspension of broker/freight forwarder operating
authority; surety or trust responsibilities in cases of broker/freight
forwarder financial failure or insolvency; enforcement authority; and
entities eligible to provide trust funds for form BMC-85 trust fund
filings; and (2) the November 16, 2022, interim guidance regarding
FMCSA's interpretation of the definitions of broker and bona fide
agents as it relates to all brokers of transportation by motor vehicle.
This FMCSA-hosted listening session will be open to all interested
persons and will take place concurrently with the Mid America Trucking
Show (MATS) in Louisville, KY. All comments will be transcribed and
placed in the public dockets for both regulatory actions. Individuals
with diverse experiences and perspectives are encouraged to attend.

DATES: The public listening session will be held on Friday, March 31,
2023, from 10 a.m. to 11 a.m. ET. The session will be held in person.
The listening session may end early if all participants wishing to
express their views have done so.
    Public Comment: The in-person session will allow members of the
public to make brief statements to the panel.

ADDRESSES: The meeting will be held at the Kentucky Expo Center, 937
Phillips Lane, Louisville, KY 40209, in Room B104. Please arrive early
to allow time to check in and arrive at the room. Attendees should
preregister using this link: https://www.eventbrite.com/e/fmcsa-session-2-broker-regulatory-session-tickets-549535173497.

FOR FURTHER INFORMATION CONTACT: Mr. Jeffrey L. Secrist, Chief,
Registration, Licensing, and Insurance Division, Office of
Registration, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001;<PHONE_NUMBER>; [email protected].
    Services for Individuals with Disabilities: FMCSA is committed to
providing equal access to the listening session. For accommodations for
persons with disabilities, please email [email protected] at least 2
weeks in advance of the meeting to allow time to make appropriate
arrangements.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages participation in the session and providing of
comments. Members of the public may submit written comments to the
public dockets for these actions using any of the following methods:

A. Submitting Comments

    If you submit a comment, please include the appropriate docket
number for the topic you are commenting on. The docket number for the
NPRM regarding broker and freight forwarder financial responsibility
requirements is FMCSA-2016-0102. The docket number for the interim
guidance on definitions of broker and bona fide agents is FMCSA-2022-
0134. You may submit your comments and material online or by mail or
hand delivery, but please use only one of these methods. FMCSA
recommends that you include your name, email address, or a phone number
in the body of your document.
    To submit your comment online, go to www.regulations.gov. Insert
the docket number (``FMCSA-2016-0102'' for the NPRM or ``FMCSA-2022-
0134'' for the interim guidance) in the keyword box and click
``Search.'' Choose the document you want to comment on and click the
``Comment'' button. Follow the online instructions for submitting
comments.
    FMCSA will consider all comments and material received during the
comment periods for these dockets.

B. Viewing Comments and Documents

    To view comments, go to www.regulations.gov and insert the docket
number (``FMCSA-2016-0102'' for the NPRM or ``FMCSA-2022-0134'' for the
interim guidance) in the keyword box and click ``Search.'' Choose the
NPRM or the interim guidance and click ``Browse Comments.'' If you have
questions on viewing or submitting material to the docket, contact
Dockets Operations at<PHONE_NUMBER>. Business

hours are from 8:00 a.m. to 4:30 p.m. ET, Monday through Friday, except
Federal holidays. You may also submit or view docket entries in person
or by mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE, West Building, Ground Floor, Room W12-140, Washington, DC 20590-
0001. To be sure someone is there to help you, please call (202) 366-
9317 or<PHONE_NUMBER> before visiting Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 13301(a) and 5 U.S.C. 553(c), DOT
solicits comments from the public to better inform its rulemaking
process. DOT posts these comments, without edit, including any personal
information the commenter provides, to www.regulations.gov, as
described in the system of records notice (DOT/ALL-14 FDMS), which can
be reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the
name of the submitter.

II. Background

    FMCSA believes it is in the public interest to host a public
listening session to receive additional comments on matters within
FMCSA's jurisdiction, including those relating to regulation of
property brokers, freight forwarders, and dispatch services.
Accordingly, FMCSA is announcing this listening session, being held at
10:00 a.m. on March 31, 2023, in Louisville, KY, concurrently with the
2023 MATS conference. FMCSA's listening session is open to the public
and a link to register to attend is available in the ADDRESSES section
above. Registration with the MATS conference is not required to attend
FMCSA's listening session.
    FMCSA is currently accepting comments on a NPRM concerning the
implementation of certain requirements under the Moving Ahead for
Progress in the 21st Century Act (MAP-21) (88 FR 830, Docket FMCSA-
2016-0102). Previously, FMCSA implemented the MAP-21 requirement to
increase the financial security amounts for brokers of household goods
and other property brokers and established new financial security
requirements for freight forwarders. The Agency is now proposing
regulations in five separate areas pertaining to broker/freight
forwarder financial responsibility: assets readily available; immediate
suspension of broker/freight forwarder operating authority; surety or
trust responsibilities in cases of broker/freight forwarder financial
failure or insolvency; enforcement authority; and entities eligible to
provide trust funds for form BMC-85 trust fund filings. By a separate
Federal Register notice, FMCSA is extending the comment period for this
NPRM from March 6, 2023, to April 6, 2023.
    In addition, FMCSA is also accepting further comments on the
interim guidance issued on November 17, 2022, regarding FMCSA's
interpretation of the definitions of broker and bona fide agents as it
relates to all brokers of transportation by motor vehicle (87 FR 68635,
FMCSA-2022-0134). Although the interim guidance took effect immediately
upon publication in the Federal Register, FMCSA is seeking additional
comments and will issue final guidance by the statutory deadline of
June 16, 2023. By a separate Federal Register notice, FMCSA is
reopening the comment period for the interim guidance, which closed on
January 17, 2023. Comments will now be accepted from March 31, 2023,
until April 6, 2023.

III. Meeting Participation

    The listening sessions are open to the public. Speakers' remarks
will be limited to 3 minutes each.

Robin Hutchinson,
Administrator.
[FR Doc. 2023-04720 Filed 3-7-23; 8:45 am]
BILLING CODE 4910-EX-P