[Federal Register Volume 84, Number 172 (Thursday, September 5, 2019)]
[Notices]
[Pages 46742-46744]
[FR Doc No: 2019-19113]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3327]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on E6(R2) Good Clinical
Practice; International Council for Harmonisation; Integrated Addendum
to International Council for Harmonisation E6(R1)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
recommendations found in Agency guidance pertaining to the development
of a system to manage quality as well as information to include in a
clinical study report about the quality management approach.

DATES: Submit either electronic or written comments on the collection
of information by November 4, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 4, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2015-D-3327 for ``Guidance for Industry on E6(R2) Good Clinical
Practice; International Council for Harmonisation; Integrated Addendum
to ICH E6(R1).'' 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.
     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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an

existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on E6(R2) Good Clinical Practice; International
Council for Harmonisation; Integrated Addendum to ICH E6(R1)

OMB Control Number 0910-0843--Extension

    This information collection request supports recommendations found
in the Agency guidance entitled ``E6(R2) Good Clinical Practice;
Integrated Addendum to ICH E6(R1)'' (ICH E6(R2). The guidance was
originally prepared under the auspices of the International Council for
Harmonisation (ICH) (formerly the International Conference on
Harmonisation); it amends the ICH guidance for industry entitled ``E6
Good Clinical Practice: Consolidated Guidance'' (issued in April 1996).
The guidance is intended to facilitate implementation of improved and
more efficient approaches to clinical trial design, including conduct,
oversight, recording, and reporting. This is intended to increase
clinical trial quality and efficiency while continuing to ensure human
subject protection and reliability of trial results. Included in the
guidance are additions identified as ``ADDENDUM'' and marked with
vertical lines on both sides of the text.
    Standards regarding electronic records and essential documents
intended to increase clinical trial quality and efficiency have also
been updated. The guidance is available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1.
    We estimate the burden of the information collection as follows:

                                           Table 1--Estimated Annual Recordkeeping Burden for Human Drugs \1\
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      Guidance for industry on E6(R2) good clinical practice;                            Number of                      Average  burden
  International Council for Harmonisation; integrated  addendum to      Number of       records per      Total annual         per          Total hours
                             ICH E6(R1)                               recordkeepers     recordkeeper       records       recordkeeping
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Section 5. Quality Management (including sections 5.0.1 to 5.0.7)--           1,457                1            1,457               60           87,420
 Developing a Quality Management System............................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                             Table 2--Estimated Annual Reporting Burden for Human Drugs \1\
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      Guidance for industry on E6(R2) good clinical practice;                            Number of
  International Council for Harmonisation; integrated  addendum to      Number of      responses per     Total annual   Average  burden    Total hours
                             ICH E6(R1)                                respondents       respondent       responses      per  response
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Section 5.0.7. Risk Reporting--Describing the Quality Management              1,457              4.6            6,702                3           20,106
 Approach Implemented in a Clinical Trial and Summarizing Important
 Deviations From the Predefined Quality Tolerance Limits and
 Remedial Actions Taken in the Clinical Study Report...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                            Table 3--Estimated Annual Recordkeeping Burden for Biologics \1\
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      Guidance for industry on E6(R2) good clinical practice;                            Number of                      Average  burden
International Council for Harmonisation; integrated addendum to ICH     Number of       records per      Total annual         per          Total hours
                               E6(R1)                                 recordkeepers     recordkeeper       records       recordkeeping
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Section 5. Quality Management (including sections 5.0.1 to 5.0.7)--             423                1              423               60           25,380
 Developing a Quality Management System............................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                              Table 4--Estimated Annual Reporting Burden for Biologics \1\
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      Guidance for industry on E6(R2) good clinical practice;                            Number of
International Council for Harmonisation; integrated addendum to ICH     Number of      responses per     Total annual   Average  burden    Total hours
                               E6(R1)                                  respondents       respondent       responses      per  response
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Section 5.0.7. Risk Reporting--Describing the Quality Management                423             1.56              660                3            1,980
 Approach Implemented in a Clinical Trial and Summarizing Important
 Deviations From the Predefined Quality Tolerance Limits and
 Remedial Actions Taken in the Clinical Study Report...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In table 1, we estimate 1,457 sponsors of clinical trials of human
drugs will develop approximately 1,457 quality management systems per
year (as described in ICH E6(R2) in section 5.0, including sections
5.0.1 to 5.0.7). We assume it will take respondents 60 hours to develop
and implement each quality management system, totaling 87,420 hours
annually. The estimated number of sponsors who will develop a quality
management system as described in ICH E6(R2) is based on the number of
annual investigational new drug applications (INDs) and new drug
applications (NDAs) submitted to FDA's Center for Drug Evaluation and
Research. The estimated number of hours we assume it takes to develop a
quality management system is based on informal interactions with
industry about activities that support drug development plans.
    In table 2, we estimate 1,457 sponsors of clinical trials of human
drugs will describe the quality management approach implemented in a
clinical trial and summarize important deviations from the predefined
quality tolerance limits and remedial actions taken in the clinical
study report (as described in section 5.0.7 of ICH E6(R2)). We further
estimate that sponsors will submit approximately 4.6 responses per
respondent and that it will take sponsors 3 hours to complete this
reporting task, totaling 20,106 reporting hours annually. These
estimates are based on our past experiences with INDs and NDAs.
    In table 3, we estimate 423 sponsors of clinical trials of
biological products will develop 423 quality management systems per
year (as described in ICH E6(R2) in section 5.0, including sections
5.0.1 to 5.0.7). We assume it will take respondents 60 hours to develop
and implement each quality management system, totaling 25,380 hours
annually. The estimated number of sponsors who will develop a quality
management system as described in ICH E6(R2) is based on the number of
annual INDs and biologics license applications (BLAs) submitted to
FDA's Center for Biologics Evaluation and Research. The estimated
number of hours we assume it takes to develop a quality management
system is based on informal interactions with industry about activities
that support drug development plans.
    In table 4, we estimate 423 sponsors of clinical trials of
biological products will describe the quality management approach
implemented in a clinical trial and summarize important deviations from
the predefined quality tolerance limits and remedial actions taken in a
clinical study report (as described in section 5.0.7 of ICH E6(R2)). We
further estimate that sponsors will submit approximately 660 responses
per respondent and that it will take sponsors 3 hours to complete this
reporting task, totaling 1,980 reporting hours annually. As described
previously, these estimates are based on past experiences with INDs and
BLAs submitted to FDA.
    Although our estimated burden for the information collection
reflects an overall decrease of 433 hours, we have increased the
estimate by 861 records. We are making this adjustment based on an
increase in the number of submissions we received over the last few
years.

    Dated: August 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19113 Filed 9-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Rules and Regulations]
[Pages 57898-57901]
[FR Doc No: 2023-18182]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0797; FRL-10971-01-OCSPP]

Aspergillus flavus strain TC16F, TC35C, TC38B, and TC46G;
Amendment to Temporary Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing temporary tolerance
exemptions for residues of Aspergillus flavus strains TC16F, TC35C,
TC38B, and TC46G by establishing permanent tolerance exemptions for use
in or on all food and feed commodities of field corn, popcorn, and
sweet corn. Interregional Research Project Number 4 (IR-4) submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting to amend the existing temporary tolerance exemptions for
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G. This
regulation eliminates the need to establish a maximum permissible level
for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and
TC46G under FFDCA when used in accordance with label directions and
good agricultural practices.

DATES: This regulation is effective August 24, 2023. Objections and
requests for hearings must be received on or before October 23, 2023
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0797, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20004. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and OPP Docket is<PHONE_NUMBER>. For the latest status
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Madison Le, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0797 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 23, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this
time, because of the COVID-19 pandemic, the judges and staff of the
Office of Administrative Law Judges are working remotely and not able
to accept filings or correspondence by courier, personal delivery, or
commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at<PHONE_NUMBER>. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0797, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-
10579-01), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 1E8975) by IR-4, North Carolina State
University, 1730 Varsity Drive, Suite 210, Venture IV, Raleigh, NC
27606, on behalf of the Texas Corn Producers Board, 4205 N Interstate
27, Lubbock, Texas 79403. The petition requested that 40 CFR 180.1338
be amended to establish an amendment of the existing temporary
tolerance exemptions for the microbial pesticides Aspergillus flavus
strains TC16F, TC35C, TC38B, and TC46G in or on all food and feed
commodities of field corn, popcorn, and sweet corn. That notice
referenced a summary of the petition prepared by the petitioner IR-4
and available in the docket via https://www.regulations.gov. EPA
received no comments in response to the notice of filing.
    EPA modified language from the requested tolerance exemption and
changed ``exemption'' to ``exemptions'' in the amended tolerance
exemption expression. The reason for this change is explained in Unit
III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G and
considered their validity, completeness, and reliability, as well as
the relationship of this information to human risk. A full explanation
of the data upon which EPA relied and its risk assessment based on
those data can be found within the document entitled ``Human Health
Risk Assessment of Aspergillus flavus strain TC16F, Aspergillus flavus
strain TC35C, Aspergillus flavus strain TC38B, and Aspergillus flavus
strain TC46G, New Active Ingredients, in FourSure

Proposed for Registration and an Associated Petition Requesting a
Tolerance Exemption'' (Human Health Risk Assessment of Aspergillus
flavus strains TC16F, TC35C, TC38B, and TC46G). This document, as well
as other relevant information, is available in the docket for this
action as described under ADDRESSES.
    The toxicological profiles of Aspergillus flavus strains TC16F,
TC35C, TC38B, and TC46G were previously described in the ``Review of
Product Identity, Human Health Data, and Petition for a Temporary
Tolerance Exemption for the IR-4 and Texas Corn Producers Board
FourSure Experimental Use Permit 5E8397,'' available in docket EPA-HQ-
OPP-2015-0742 and remain unchanged at this time. Based upon its
evaluation, EPA concludes that, with regard to humans, Aspergillus
flavus strains TC16F, TC35C, TC38B, and TC46G are not anticipated to be
toxic, pathogenic, or infective via any reasonably foreseeable route of
exposure. Although there is potential for dietary and non-occupational
exposure to residues of Aspergillus flavus strains TC16F, TC35C, TC38B,
and TC46G, there is not a concern due to the lack of potential for
adverse effects. Because there are no threshold levels of concern with
the toxicity, pathogenicity, or infectivity of Aspergillus flavus
strains TC16F, TC35C, TC38B, and TC46G, EPA determined that no
additional margin of safety is necessary to protect infants and
children as part of the qualitative assessment conducted.
    Based upon its evaluation in the Human Health Risk Assessment of
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, which
concludes that there are no risks of concern from aggregate exposure to
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Aspergillus flavus strains TC16F, TC35C, TC38B,
and TC46G.

B. Analytical Enforcement Methodology

    An analytical method is not required for Aspergillus flavus strains
TC16F, TC35C, TC38B, and TC46G because EPA is amending temporary
exemptions from the requirement of a tolerance without any numerical
limitations.

C. Revisions to the Requested Amendment to a Tolerance Exemption

    One modification was made to the requested tolerance exemption. EPA
changed ``exemption'' to ``exemptions'' as four different active
ingredients are covered with this action.

D. Conclusion

    Therefore, the existing Aspergillus flavus strains TC16F, TC35C,
TC38B, and TC46G temporary tolerance exemptions are amended by
establishing permanent tolerance exemptions for residues of Aspergillus
flavus strains TC16F, TC35C, TC38B, and TC46G in or on all food and
feed commodities of corn, field; corn, pop; and corn, sweet when used
in accordance with label directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action amends temporary tolerance exemptions under FFDCA
section 408(d) in response to a petition submitted to EPA. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are amended on the basis of a
petition under FFDCA section 408(d), such as the tolerance exemptions
in this action, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
governments, on the relationship between the National Government and
the States or Tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 16, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Revise Sec.  180.1338 to read as follows:

Sec.  180.1338   Aspergillus flavus strains TC16F, TC35C, TC38B, and
TC46G; exemptions from the requirement of a tolerance.

    Exemptions from the requirement of a tolerance are established for
residues of

Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on all
food and feed commodities of corn, field; corn, pop; and corn, sweet
when used in accordance with label directions and good agricultural
practices.

[FR Doc. 2023-18182 Filed 8-23-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Notices]
[Page 39104]
[FR Doc No: 2016-14122]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2010-0034]

Port Authority Trans-Hudson Corporation's Request for Positive
Train Control Safety Plan Approval and System Certification

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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

SUMMARY: This document provides the public with notice that the Port
Authority Trans-Hudson Corporation (PATH) submitted to FRA its Positive
Train Control Safety Plan (PTCSP), Revision 3.0, dated March 23, 2016.
PATH asks FRA to approve its PTCSP and issue a Positive Train Control
(PTC) System Certification for PATH's Communication Based Train Control
(CBTC) system, under Title 49 Code of Federal Regulations (CFR)
236.1009, Procedural requirements, and 236.1015, PTC Safety Plan
content requirements and PTC System Certification. This notice was
assigned to Docket Number FRA-2010-0034.

DATES: FRA will consider communications received by July 15, 2016
before taking final action on the PTCSP. FRA may consider comments
received after that date if practicable.

ADDRESSES: All communications concerning this proceeding should refer
to Docket Number FRA-2010-0034 and may be submitted by any of the
following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: Dr. Mark Hartong, Senior Scientific
and Technical Advisor at<PHONE_NUMBER>, or<EMAIL_ADDRESS>or
Mr. David Blackmore, Railroad Safety Program Manager for Applied
Technology at<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In its revised Positive Train Control
Implementation Plan, referenced in its PTCSP, PATH asserts its CBTC
system is a vital standalone PTC system as defined in 49 CFR
236.1015(e). The PTCSP describes PATH's CBTC implementation and the
associated CBTC safety processes, safety analyses, and test,
validation, and verification processes used during development of CBTC.
The PTCSP also contains PATH's operational and support requirements and
procedures.
    PATH's PTCSP and the accompanying request for approval and system
certification are available for review online at www.regulations.gov
(Docket Number FRA-2010-0034) and in person at DOT's Docket Operations
Facility, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590.
The Docket Operations Facility is open from 9 a.m. to 5 p.m., Monday
through Friday, except Federal Holidays.
    Interested parties are invited to comment on the PTCSP by
submitting written comments or data. During its review of the PTCSP,
FRA will consider any comments or data submitted. However, FRA may
elect to not respond to any particular comment and, under 49 CFR
236.1009(d)(3), FRA maintains the authority to approve or disapprove
the PTCSP at its sole discretion. FRA does not anticipate scheduling a
public hearing regarding PATH's PTCSP because the circumstances do not
appear to warrant a hearing. If any interested party desires an
opportunity for oral comment, the party should notify FRA in writing
before the end of the comment period and specify the basis for his or
her request.

Privacy Act Notice

    Anyone may search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 49 CFR 211.3, Participation by interested persons, FRA solicits
comments from the public to better inform its decisions. 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 you can review at
www.dot.gov/privacy. See http://www.regulations.gov/#!privacyNotice for
the privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2016-14122 Filed 6-14-16; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8086-8088]
[FR Doc No: 2016-03226]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-B-1539]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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

SUMMARY: On October 27, 2015, FEMA published in the Federal Register a
proposed flood hazard determination notice at 80 FR 65789 that
contained a table which included a Web page address through which the
Preliminary Flood Insurance Rate Map (FIRM), and where applicable, the
Flood Insurance Study (FIS) report for the communities listed in the
table could be accessed. The information available through the Web page
address has been updated. Subsequently, FEMA is no longer proposing
flood hazard determination changes for the City of Atlanta as
identified in the above-referenced publication. The table provided here
represents the proposed flood hazard determinations and communities
affected for Clayton County, Georgia, and Incorporated Areas.

DATES: Comments are to be submitted on or before May 17, 2016.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the table below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1539, to
Luis Rodriguez, Chief, Engineering

Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 80
FR 65789 in the October 27, 2015, issue of the Federal Register, FEMA
published a table titled ``Clayton County, Georgia, and Incorporated
Areas''. This table contained a Web page address through which the
Preliminary FIRM, and where applicable, the FIS report for the
communities listed in the table could be accessed online. The
information available through the Web page address has been updated and
is to be used in lieu of the information previously available.
Subsequently, FEMA is no longer proposing flood hazard determination
changes for the City of Atlanta as identified in the above-referenced
publication.
    In this document, FEMA is publishing a table containing the
accurate information. The information provided below should be used in
lieu of that previously published.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: January 22, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Clayton County, Georgia, and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
           Project: 12-04-7371S Preliminary Date: May 29, 2015
------------------------------------------------------------------------
City of Forest Park....................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
City of Jonesboro......................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
City of Lake City......................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
City of Lovejoy........................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
City of Morrow.........................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
City of Riverdale......................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
Unincorporated Areas of Clayton County.  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
------------------------------------------------------------------------

[FR Doc. 2016-03226 Filed 2-16-16; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]
[Page 13109-13111]
[DOCID:fr12mr08-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0228; Directorate Identifier 2007-NM-107-AD;
Amendment 39-15421; AD 2008-06-09]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-200 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 737-200 series airplanes. This AD requires repetitive
inspections to detect cracking of the support fittings of the Krueger
flap actuators, and corrective actions if necessary. This AD also
requires eventual replacement of any existing aluminum support fitting
on each wing with a steel fitting, and modification of the aft
attachment of the actuator. Doing these actions terminates the
repetitive inspection requirements. This AD results from reports of
cracking due to fatigue and stress corrosion of the support fittings of
the Krueger flap actuator. We are issuing this AD to prevent cracking
of the support fittings, which could result in fracturing of the
actuator attach lugs, separation of the actuator from the support
fitting, severing of the hydraulic lines, resultant loss of hydraulic
fluids, and consequent reduced controllability of the airplane.

DATES: This AD is effective April 16, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 16,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 737-200 series airplanes. That NPRM was published
in the Federal Register on November 26, 2007 (72 FR 65909). That NPRM
proposed to require repetitive inspections to detect cracking of the
support fittings of the Krueger flap actuators, and corrective actions
if necessary. The NPRM also proposed to require eventual replacement of
any existing aluminum support fitting on each wing with a steel
fitting, and modification of the aft attachment of the actuator. Doing
these actions terminates the repetitive inspection requirements.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the one comment received. Boeing supports the
NPRM.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Costs of Compliance

    There are about 13 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
                Action                   Work hours     Average labor       Parts          Cost per airplane       registered           Fleet cost
                                                        rate per hour                                               airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection...........................               5             $80              $0  $400, per inspection                   3  $1,200, per inspection
                                                                                cycle.                                    cycle.
Replacement..........................              88              80          29,642  $36,682.................               3  $110,046.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 AD:

2008-06-09 Boeing: Amendment 39-15421. Docket No. FAA-2007-0228;
Directorate Identifier 2007-NM-107-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective April 16,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-200 series airplanes,
line numbers 814 through 826 inclusive, certificated in any
category.

Unsafe Condition

    (d) This AD results from reports of cracking due to fatigue and
stress corrosion of the support fittings of the Krueger flap
actuator. We are issuing this AD to prevent cracking of the support
fittings, which could result in fracturing of the actuator attach
lugs, separation of the actuator from the support fitting, severing
of the hydraulic lines, resultant loss of hydraulic fluids, and
consequent reduced controllability of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Repetitive Inspections

    (f) Within 12 months after the effective date of this AD, do a
high frequency eddy current (HFEC) inspection to detect cracking of
the support fittings of the Krueger flap actuator on each wing, in
accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 737-57-1129, Revision 3, dated March 19,
2007.
    (1) If no cracking is detected, repeat the inspection thereafter
at intervals not to exceed 3,000 flight hours until the terminating
action required by paragraph (g) of this AD is accomplished.
    (2) If any cracking is detected, before further flight, do the
replacement and modification specified in paragraph (g) of this AD.

Terminating Action

    (g) Within 60 months after the effective date of this AD:
Replace any existing Krueger flap actuator aluminum support fitting
on each wing with a steel fitting, and modify the actuator aft
attachment, in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 737-57-1129, Revision 3,
dated March 19, 2007. Doing this replacement and modification
terminates the repetitive inspection requirements of paragraph (f)
of this AD.

Parts Replacement

    (h) As of the effective date of this AD, no person may install
on any airplane any aluminum support fitting (actuator support
assembly) identified in the ``Existing Part Number'' column of
paragraph 2.C. of Boeing Special Attention Service Bulletin 737-57-
1129, Revision 3, dated March 19, 2007.

Actions Accomplished in Accordance With Previous Revisions of Service
Bulletin

    (i) Actions done before the effective date of this AD in
accordance with the service bulletins listed in Table 1 of this AD,
are acceptable for compliance with the corresponding requirements of
this AD.

            Table 1.--Previous Revisions of Service Bulletins
------------------------------------------------------------------------
                                    Revision
     Boeing service bulletin         level               Date
------------------------------------------------------------------------
737-57-1129......................          1  Oct. 30, 1981.
737-57-1129......................          2  May 28, 1998.
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District

Office (FSDO), or lacking a PI, your local FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (k) You must use Boeing Special Attention Service Bulletin 737-
57-1129, Revision 3, dated March 19, 2007, to do the actions
required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on February 28, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-4674 Filed 3-11-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Notices]
[Pages 38430-38431]
[FR Doc No: 2011-16426]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.
    Extension:
    Rule 15c2-5; SEC File No. 270-195; OMB Control No. 3235-0198.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of an extension of the
previously approved collection of information provided for in Rule
15c2-5 (17 CFR 240.15c2-5), under the Securities Exchange Act of 1934
(15 U.S.C. 78 et seq.) (``Exchange Act'').
    Rule 15c2-5 prohibits a broker-dealer from arranging or extending
certain loans to persons in connection with the offer or sale of
securities unless, before any element of the transaction is entered
into, the broker-dealer: (1) Delivers to the person a written statement
containing the exact nature and extent of the person's obligations
under the loan arrangement; the risks and disadvantages of the loan
arrangement; and all commissions, discounts, and other remuneration
received and to be received in connection with the transaction by the
broker-dealer or certain related persons (unless the person receives
certain materials from the lender or broker-dealer which contain the
required information); and (2) obtains from the person information on
the person's financial situation and needs, reasonably determines that
the transaction is suitable for the person, and retains on file and
makes available to the person on request a written statement setting
forth the broker-dealer's basis for determining that the transaction
was suitable. The collection of information required by Rule 15c2-5 is
necessary to execute the Commission's mandate under the Exchange Act to
prevent fraudulent, manipulative, and deceptive acts and practices by
broker-dealers.
    The Commission estimates that there are approximately 50
respondents that require an aggregate total of 600 hours to comply with
Rule 15c2-5. Each of these approximately 50 registered broker-dealers
makes an estimated six annual responses, for an aggregate total of 300
responses per year. Each response takes approximately two hours to
complete. Thus, the total compliance burden per year is 600 burden
hours. The approximate cost per hour is $50.00 for clerical labor,
resulting in a total compliance cost of $30,000 (600 hours @ $50.00 per
hour). These reflect internal labor costs; there are no external labor,
capital, or start-up costs.
    Although Rule 15c2-5 does not specify a retention period or record-
keeping requirement under the rule, broker-dealers are required to
preserve the records for a period no less than six years pursuant to
Rule 17a-4(c). The information required under Rule 15c2-5 is necessary
for broker-dealers to engage in the lending activities

prescribed in the Rule. Rule 15c2-5 does not assure confidentiality for
the information retained under the rule.\1\
---------------------------------------------------------------------------

    \1\ The records required by Rule 15c2-5 would be available only
for examination purposes of the Commission staff, state securities
authorities, and the self-regulatory organizations. Subject to the
provisions of the Freedom of Information Act, 5 U.S.C. 552, and the
Commission's rules thereunder (17 CFR 200.80(b)(4)(iii)), the
Commission does not generally publish or make available information
contained in any reports, summaries, analyses, letters, or memoranda
arising out of, in anticipation of, or in connection with an
examination or inspection of the books and records of any person or
any other investigation.
---------------------------------------------------------------------------

    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the Paperwork Reduction Act that
does not display a valid OMB control number.
    Background documentation for this information collection may be
viewed at the following link, http://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 e-mail to<EMAIL_ADDRESS>; and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312 or send an e-mail to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: June 26, 2011.
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-16426 Filed 6-29-11; 8:45 am]
BILLING CODE 8011-01-P